Carcinoma, Renal CellNCT03538717

"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

An observational study of Carcinoma, Renal Cell, run by Pfizer at 40 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Renal Cell
How many people: 157 participants
Where: 40 sitesSpain
Study dates: 19 Apr 2018to 1 Mar 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: - Age ≥ 18 years * Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment * Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment. * For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Who may be able to join

Age ≥ 18 years
Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment.
For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Who cannot join

Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

Spain40 sites

Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805
Complejo Hospitalario la Mancha Centro
Alcázar de San Juan, Ciudad REAL, 13600
Hospital Universitario Fundacion Alcorcón
Alcorcón, Madrid, 28922
Hospital del Mar
Barcelona, 08003
Hospital Universitario Vall d'Hebrón
Barcelona, 08036
HU Clinic i Provincial
Barcelona, 08036
Hospital Universitario Sant Pau i Santa Creu
Barcelona, 08041
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Reina Sofía
Córdoba, 14004
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario de Canarias
La Cuesta, Santa Cruz de Tenerife, Tenerife, 38320
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
HU De León
León, 24080
Hospital Universitario Lucus Augusti (HULA_ Lugo)
Lugo, 27003
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Fundación Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Centro Integral Oncológico Clara Campal
Madrid, 28050
Hospital Universitario Rey Juan carlos
Móstoles, Madrid, 28933
Complejo Hospitalario Universitario de Ourense CHUOU
Ourense, 32005
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07120
HU de Navarra, Pamplona
Pamplona, Navarre, 31008
Hospital Infanta Cristina
Parla, Madrid, 28981
Hospital Universitario Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario Infanta Sofía
San Sebatián de Los Reyes, Madrid, 28703
Hospital Universitario Nuestra Señora de la Candelaria, Tenerife
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Universitario Santiago de Compostela
Santiago de Compostela, 15076
Hospita General Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
Hospital Sant Pau i Santa Tecla
Tarragona, Barcelona, 43003
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, 08221
Hospita Virgen de la Salud de Toledo
Toledo, 45004
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro
Vigo, 36312
H. Universitario Miguel Servet, Zaragoza
Zaragoza, 50009
Hospital Clínico Uiversitario Lozano Blesa
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Retrospective Analysis of Clinical Factors Associated With Greater Benefit of Axitinib in Metastatic Renal Cancer (AXILONG Study)

Read the detailed description

To describe the clinical profile of patients with a long response to Axitinib and to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients.

For this study are defined as "long responder", those patients who has a Progression Free Survival (PFS) of at least 9 months since the initiation of Axitinib treatment, and "refractory patients" those who have Progression Disease (PD) in the first response assessment since the initiation of Axitinib treatment (estimated PFS ≤3 months]

Secondary Objectives

To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ...
To describe the tolerability and drug management of Axitinib in this population.
To describe treatment received after Axitinib in this population.

Study procedures:

For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC.

With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

Conditions: Carcinoma, Renal Cell
Keywords: Axitinib,, Renal Carcinoma,, Long responders
Medical subject headings: Carcinoma, Renal Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
Measured: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: before first line treatment initiation), was compared between long responders and refractory participants.
Measured: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: at initiation of axitinib), was compared between long responders and refractory participants.
Measured: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: on axitinib discontinuation), was compared between long responders and refractory participants.
Measured: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Measured: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Nephrectomy is a surgical removal of kidney. Data for participants was categorized as yes and no to depict their nephrectomy status before axitinib treatment initiation and comparison was done between long responders and refractory participants.
Measured: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a Karnofsky performance status (KPS) of less than (<) 80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum lactate dehydrogenase (LDH) >1.5*upper limit of normal (ULN), corrected serum calcium level >10.0 milligram per deciliter (mg/dL) and hemoglobin < lower limit of normal (LLN).
Measured: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.
Measured: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.
Measured: On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: at initiation of axitinib) was compared between long responders and refractory participants.
Measured: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: on discontinuation of axitinib) was compared between long responders and refractory participants.
Measured: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
In this outcome measure, data for participants who had renal cells with different type of histology as 100% clear cells, 100% non-clear cells, majority component of clear cells and majority component of non-clear cells was compared between long responders and refractory participants.
Measured: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Duration of first line treatment with TKI was stratified into 0-3 months, 3-6 months, 6-9 months, 9-12 months and >12 months and compared between long responders and refractory participants.
Measured: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
In this outcome measure, data for participants with their best response as complete response (CR) and partial response (PR), stable disease (SD) or progressive-disease (PD) to the first line treatment with TKI, was compared between long responders and refractory participants. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of >=1 new lesions. SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters during treatment.
Measured: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
Measured: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
In this outcome measure, data for participants with different metastatic sites as lymph nodes, central nervous system (CNS), hepatic, pulmonary, bone and another site of metastasis at diagnosis of advance or mRCC before axitinib treatment initiation, was compared between long responders and refractory participants.
Measured: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
In this outcome measure, data for different laboratory parameters at initiation of first line treatment: LDH level >1.5*ULN, haemoglobin (Hgb) levels <=LLN, corrected Ca levels >10 mg/dL, neutrophil levels >ULN, platelet levels >ULN and neutrophil-to-lymphocyte ratio of <=3 was compared between long responders and refractory participants.
Measured: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
In this outcome measure, data for smoking habit of participants was compared between long responders and refractory participants.
Measured: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)

Secondary outcomes (19)

Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders
PFS was defined as the time from the start of axitinib treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.
Measured: Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders
TTP was defined as the time from the start of axitinib treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.
Measured: Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])
Overall Survival (OS) From Axitinib Treatment in Group of Long Responders
OS was defined as the time from the date of start of axitinib treatment to the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.
Measured: Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
In this outcome measure, data for number of participants with best response to axitinib as second line of treatment and subsequent treatment was collected. Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment. Subsequent treatment referred to further treatment after second line of treatment.
Measured: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
PFS was defined as the time from the start of axitinib as second line of treatment and subsequent treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.
Measured: From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)
Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
ORR was defined as the number of participants with CR or PR. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters.
Measured: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
CBR was defined as the frequency of participants with CR, PR or SD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.
Measured: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
TTP was defined as the time from the start of second line of treatment and subsequent treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.
Measured: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
OS was defined as the time from the date of start of second line of treatment and subsequent treatment till the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.
Measured: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Duration of Axitinib Treatment: All Participants
Duration of treatment with axitinib was the time from date of start of axitinib treatment to date of end of axitinib treatment or of latest follow-up if not suspended.
Measured: Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
Percentage of participants whose axitinib dose was titrated and increased to more than 5mg dose at least 1 time in 12 hours (twice daily), are reported in this outcome measure.
Measured: For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
Percentage of participants whose axitinib dose was reduced 5 mg dose at least 1 time in 12 hours (twice daily) are reported in this outcome measure.
Measured: For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)
Number of Participants With Adverse Events (AE): All Participants
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both SAEs and non-SAEs.
Measured: For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)
Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants
Measured: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants
Measured: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Duration of Subsequent Treatments Post Axitinib Treatment: All Participants
Measured: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment
Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.
Measured: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants
In this outcome measure, participants who stopped subsequent treatments after axitinib discontinuation due to any reasons like PD, toxicity and others are reported.
Measured: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment
OS was defined as the time from the date of randomization to treatment up to the date of death due to any cause.
Measured: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20181 Mar 2019

First posted29 May 2018
Study start19 Apr 2018
Primary completion1 Mar 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03538717
Sponsor's protocol ID: A4061089
Other IDs: AXILONG
Status last verified: Feb 2022
First submitted: 19 Jan 2018
Last updated: 17 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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What happens when the study ends?

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RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
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Not yet recruitingPhase 2
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Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

All Carcinoma, Renal Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective Analysis of Clinical Factors Associated With Greater Benefit of Axitinib in Metastatic Renal Cancer (AXILONG Study)
ClinicalTrials.gov ID: NCT03538717
Acronym / sponsor ID: A4061089
Conditions: Carcinoma, Renal Cell
Keywords: Axitinib,, Renal Carcinoma,, Long responders
Study type: Observational
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 19 Apr 2018 (actual)
Primary completion: 1 Mar 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 13 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Secondary Objectives

To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ...
To describe the tolerability and drug management of Axitinib in this population.
To describe treatment received after Axitinib in this population.

Study procedures:

For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC.

With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: - Age ≥ 18 years * Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment * Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment. * For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Key inclusion criteria (4 listed)

Age ≥ 18 years

Key exclusion criteria (1 listed)

Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: before first line treatment initiation), was compared between long responders and refractory participants.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: at initiation of axitinib), was compared between long responders and refractory participants.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants
Time frame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: on axitinib discontinuation), was compared between long responders and refractory participants.
Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
Nephrectomy is a surgical removal of kidney. Data for participants was categorized as yes and no to depict their nephrectomy status before axitinib treatment initiation and comparison was done between long responders and refractory participants.
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a Karnofsky performance status (KPS) of less than (<) 80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum lactate dehydrogenase (LDH) >1.5*upper limit of normal (ULN), corrected serum calcium level >10.0 milligram per deciliter (mg/dL) and hemoglobin < lower limit of normal (LLN).
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.
Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.
Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: at initiation of axitinib) was compared between long responders and refractory participants.
Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
Time frame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: on discontinuation of axitinib) was compared between long responders and refractory participants.
Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
In this outcome measure, data for participants who had renal cells with different type of histology as 100% clear cells, 100% non-clear cells, majority component of clear cells and majority component of non-clear cells was compared between long responders and refractory participants.
Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Duration of first line treatment with TKI was stratified into 0-3 months, 3-6 months, 6-9 months, 9-12 months and >12 months and compared between long responders and refractory participants.
Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
In this outcome measure, data for participants with their best response as complete response (CR) and partial response (PR), stable disease (SD) or progressive-disease (PD) to the first line treatment with TKI, was compared between long responders and refractory participants. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of >=1 new lesions. SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters during treatment.
Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
Time frame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
In this outcome measure, data for participants with different metastatic sites as lymph nodes, central nervous system (CNS), hepatic, pulmonary, bone and another site of metastasis at diagnosis of advance or mRCC before axitinib treatment initiation, was compared between long responders and refractory participants.
Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
In this outcome measure, data for different laboratory parameters at initiation of first line treatment: LDH level >1.5*ULN, haemoglobin (Hgb) levels <=LLN, corrected Ca levels >10 mg/dL, neutrophil levels >ULN, platelet levels >ULN and neutrophil-to-lymphocyte ratio of <=3 was compared between long responders and refractory participants.
Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
Time frame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
In this outcome measure, data for smoking habit of participants was compared between long responders and refractory participants.

19 secondary outcomes

Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders
Time frame: Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders
Time frame: Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])
Overall Survival (OS) From Axitinib Treatment in Group of Long Responders
Time frame: Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)
Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
Time frame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
Duration of Axitinib Treatment: All Participants
Time frame: Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
Time frame: For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
Time frame: For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)
Number of Participants With Adverse Events (AE): All Participants
Time frame: For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)
Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants
Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants
Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Duration of Subsequent Treatments Post Axitinib Treatment: All Participants
Time frame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment
Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants
Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment
Time frame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)

Results and safety

Results posted to the registry on 13 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axitinib (INLYTA)	157	157

Primary outcome: Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants

Time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year). Count of participants. Unit: Participants

Measure	Long Responders to Axitinib n = 91	Axitinib Refractory Participants n = 65
<= 65 years	58	50
> 65 years	33	15

Long Responders to Axitinib vs Axitinib Refractory Participants: p = 0.113, Chi-squared

Population analysed: FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, "Overall Number of Participants" signifies participants evaluable for this outcome measure.

Primary outcome: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants

Time frame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year). Count of participants. Unit: Participants

Measure	Long Responders to Axitinib n = 75	Axitinib Refractory Participants n = 53
ECOG: 0	49	28
ECOG: 1	23	24
ECOG: >=2	3	1

Long Responders to Axitinib vs Axitinib Refractory Participants: p = 0.228, Fisher Exact

Primary outcome: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants

Measure	Long Responders to Axitinib n = 80	Axitinib Refractory Participants n = 52
ECOG: 0	34	10
ECOG: 1	39	34
ECOG: >=2	7	8

Long Responders to Axitinib vs Axitinib Refractory Participants: p = 0.020, Chi-squared

Primary outcome: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants

Time frame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year). Count of participants. Unit: Participants

Measure	Long Responders to Axitinib n = 61	Axitinib Refractory Participants n = 53
ECOG: 0	16	9
ECOG: 1	32	24
ECOG: >=2	13	20

Long Responders to Axitinib vs Axitinib Refractory Participants: p = 0.138, Chi-squared

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Axitinib (INLYTA)	15 of 157 (9.6%)	116 of 157 (73.9%)	2 of 157

Limitations and caveats (from the sponsor): Prioritization of outcome measures was based on sponsor's discretion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Renal Cell, run by Pfizer at 40 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants (time frame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03538717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.