Metastatic Renal Cell CarcinomaPhase 2NCT01577784
Pazopanib in Second-line Therapy in Renal Cell Carcinoma
A Phase 2 study testing Pazopanib in people with Metastatic Renal Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 10 sites in Spain.
Trial summary
The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 10 sitesSpain
- Study dates
- Apr 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Signed Inform Consent
- Age ≥ 18
- Histologically confirmed diagnosis of clear cell renal carcinoma metastatic or locally recurrent unresectable.
- Patients must have received only a first-line treatment with a Tyrosine Kinase Inhibitor. Patients must have progressed during treatment or within three months after stopping treatment with these agents. Patients who discontinued treatment with a Tyrosine Kinase Inhibitor for unacceptable toxicity are also eligible for the study.
- Patients must have been previously treated by nephrectomy with removal of the primary tumor, except that there is a contraindication (eg liver I extensive bone metastatic disease or primary tumor smaller than 5 cm).
- Patients with ECOG PS 0 or 1.
Show all 16Show fewer
- To be included in the study, the renal tumor should be classified in a group of low or intermediate risk according to the Motzer classification.
- Eligibility criteria under RECIST v.1.1
- Adequate hematologic function:
- Absolute neutrophil count ≥ 1.5 x 109 / L Platelet count ≥ 100 x 109 / L Hemoglobin ≥ 9 g / dL (5.6 mmol / L). Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 X ULN. Activated partial thromboplastin time (APTT) ≤ 1.2 X ULN
- Adequate hepatic function:
- total bilirubin ≤ 1.5 X ULN ALT ≤ 2.5 x ULN
- Adequate renal function:
- Serum creatinine ≤ or 1.5 mg / dL (133 mol / L). If> 1.5 mg / dL, then the calculated creatinine clearance has to be ≥ 50 mL / min (Appendix 1).
- Urine protein / creatinine ratio <1.
- Can be included in the study of both fertile and infertile women.
Who cannot join
- Previous malignancy. May be included in the study patients with a disease-free interval of 5 years at the time of inclusion in the study and patients with non-melanoma skin carcinoma completely resected or carcinoma in situ treated successfully.
- Previous treatment with more then one Tyrosine Kinase Inhibitor or more than one previous traditional regime (eg, chemotherapy, immunotherapy or chemo-immunotherapy).
- Known history or clinical evidence of nervous system metastases or leptomeningeal carcinomatosis, except that metastases in the central nervous system have been previously treated, are asymptomatic and not requiring treatment with corticosteroids or anticonvulsant medication within six months before the first administration of pazopanib.
- Clinically significant gastrointestinal disorders that may increase the risk of bleeding gastrointestinal.
- Clinically significant gastrointestinal disorders which may affect the absorption of pazopanib.
- Presence of uncontrolled infection.
Show all 22Show fewer
- ECG QT interval longer than 480 milliseconds, according to the Bazett formula.
- History of one or more of the following cardiovascular conditions within the last 6 months prior to inclusion:
- Cardiac angioplasty or stent placement Myocardial infarction Unstable angina Surgery or coronary bypass Symptomatic peripheral vascular disease
- Congestive heart failure Class III or IV, as defined by the New York Heart Association
- Poorly controlled hypertension (defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- History of stroke (including transient ischemic attack), pulmonary embolism or deep vein thrombosis not treated within 6 months.
- Major surgery or major trauma within 28 days prior to administering the first dose of study and / or presence of any unhealed wound, fracture, or ulcer (not considered major procedures such as venous catheter placement with or without a reservoir).
- Evidence of bleeding diathesis or active bleeding.
- Endobronchial lesions known and / or lesions infiltrating major pulmonary vessels.
- Hemoptysis greater than 2.5 milliliters in the 8 weeks before the first administration of study drug.
- Any medical condition, psychiatric or any other nature, unstable or severe, which could interfere with patient safety, with the ability to give informed consent or compliance with study procedures.
- Inability or lack of willingness to discontinue the use of banned drugs listed in in the previous 14 days, or the time equivalent to 5 half-lives (whichever is greater) at baseline and during treatment with pazopanib.
- Treatment with any of the following antineoplastic therapy: radiation therapy, surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapies, investigational therapies or hormone treatments within 14 days, or the time equivalent to 5 half-lives (whichever is greater), to the administration of the first dose of pazopanib.
- Any unresolved toxicity from previous cancer therapies> Grade 1 and / or is getting worse in intensity, except for alopecia.
- Patients who are at risk of hypersensitivity to pazopanib.
- Pregnant or lactating women
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28009
Hospital 12 de Octubre
Madrid, Madrid, 28026
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07010
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
About this study
Official title: A Phase II, Opened, Not Controlled and Multicentric Clinical Trial of Pazopanib in Monotherapy to Determine Efficiency and Safety in Second-line of Treatment in Patients With Carcinoma of Advanced Renal Cells That Have Progressed or Have Not Tolerated the First Line of Treatment With Tyrosine Kinase Inhibitor
The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment safety profile for these patients in second-line treatment with pazopanib. The exploratory aim is to determine the correlation between biomarkers in patient blood and tumor samples, and the clinical results obtained with pazopanib.
Read the detailed description
Patients who progress or do not tolerate a first-line treatment with a Tyrosine Kinase Inhibitor will be included consecutively in the study. All patients will receive the same treatment regimen consisting of 800 mg / day of pazopanib in monotherapy.
All patients will receive treatment until there is evidence of progression, evidence of unacceptable toxicity, not compliance, investigator clinical decision or consent withdrawal by the patient.
After treatment, the patient will enter to the follow-up period. During this period the investigator will collect information from subsequent administered treatments and survival of all patients, regardless of the reason for withdrawal, every 8 weeks until the scheduled end of follow-up period, according to protocol. At 30 days after treatment completion, the first follow up visit will be scheduled to assess the possible occurrence of late toxicity. In those patients who complete treatment prior to objectify progression, information about the progression of the disease will be collected.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Pazopanib
- Keywords
- Advanced renal cell carcinoma, second-line treatment with pazopanib, first line of treatment with a Tyrosine Kinase Inhibitor
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Pazopanib (GW786034; Votrient®)
800 mg / day of pazopanib in monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib | Experimental | 800 mg / day of pazopanib in monotherapy Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To asses the Objective Response (Complete Response or Partial Response) which provides second-line treatment with pazopanib in patients with carcinoma of advanced renal cell who have progressed or have not tolerated a first line of treatment with a Tyrosine Kinase Inhibitor.
The Objective Response Rate will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 30 months
Secondary outcomes (2)
Overall Survival
To assess the overall survival in patients treated with second-line treatment with pazopanib.
Measured: 30 months
Treatment Safety Profile
To assess the treatment safety profile in patients treated with second-line treatment with pazopanib.
Safety was assessed using Common Toxicity Criteria (CTC) of the National Cancer Institute (NCI), version 4.0.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associació per a la Recerca Oncologica, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Trial Form Support S.L.
- Responsible party
- Sponsor
- Investigators
- Joaquim Bellmunt, MD, Study chair, Hospital del MarMarta Guix, MD, Principal investigator, Hospital del MarJuan Manuel Sepúlveda, MD, Principal investigator, Hospital 12 de OctubreEnrique Gallardo, MD, Principal investigator, Corporació Sanitaria Parc TaulíXavier García del Muro, MD, Principal investigator, Hospital Universitari de BellvitgeOlatz Etxaniz, MD, Principal investigator, Germans Trias i Pujol HospitalJosé Luis González Larriba, MD, Principal investigator, Hospital San Carlos, MadridJose Angel Arranz, MD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577784
- Sponsor's protocol ID
- APRO02-2011
- Status last verified
- Mar 2014
- First submitted
- 10 Apr 2012
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Opened, Not Controlled and Multicentric Clinical Trial of Pazopanib in Monotherapy to Determine Efficiency and Safety in Second-line of Treatment in Patients With Carcinoma of Advanced Renal Cells That Have Progressed or Have Not Tolerated the First Line of Treatment With Tyrosine Kinase Inhibitor
- ClinicalTrials.gov ID
- NCT01577784
- Acronym / sponsor ID
- APRO02-2011
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Advanced renal cell carcinoma, second-line treatment with pazopanib, first line of treatment with a Tyrosine Kinase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Associació per a la Recerca Oncologica, SpainUniversity, hospital or other
- Collaborators
- Trial Form Support S.L.
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment safety profile for these patients in second-line treatment with pazopanib. The exploratory aim is to determine the correlation between biomarkers in patient blood and tumor samples, and the clinical results obtained with pazopanib.
Detailed description
Patients who progress or do not tolerate a first-line treatment with a Tyrosine Kinase Inhibitor will be included consecutively in the study. All patients will receive the same treatment regimen consisting of 800 mg / day of pazopanib in monotherapy.
All patients will receive treatment until there is evidence of progression, evidence of unacceptable toxicity, not compliance, investigator clinical decision or consent withdrawal by the patient.
After treatment, the patient will enter to the follow-up period. During this period the investigator will collect information from subsequent administered treatments and survival of all patients, regardless of the reason for withdrawal, every 8 weeks until the scheduled end of follow-up period, according to protocol. At 30 days after treatment completion, the first follow up visit will be scheduled to assess the possible occurrence of late toxicity. In those patients who complete treatment prior to objectify progression, information about the progression of the disease will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib | Experimental | Drug: Pazopanib800 mg / day of pazopanib in monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed Inform Consent
- Age ≥ 18
- Histologically confirmed diagnosis of clear cell renal carcinoma metastatic or locally recurrent unresectable.
- Patients must have received only a first-line treatment with a Tyrosine Kinase Inhibitor. Patients must have progressed during treatment or within three months after stopping treatment with these agents. Patients who discontinued treatment with a Tyrosine Kinase Inhibitor for unacceptable toxicity are also eligible for the study.
- Patients must have been previously treated by nephrectomy with removal of the primary tumor, except that there is a contraindication (eg liver I extensive bone metastatic disease or primary tumor smaller than 5 cm).
Key exclusion criteria (22 listed)
- Previous malignancy. May be included in the study patients with a disease-free interval of 5 years at the time of inclusion in the study and patients with non-melanoma skin carcinoma completely resected or carcinoma in situ treated successfully.
- Previous treatment with more then one Tyrosine Kinase Inhibitor or more than one previous traditional regime (eg, chemotherapy, immunotherapy or chemo-immunotherapy).
- Known history or clinical evidence of nervous system metastases or leptomeningeal carcinomatosis, except that metastases in the central nervous system have been previously treated, are asymptomatic and not requiring treatment with corticosteroids or anticonvulsant medication within six months before the first administration of pazopanib.
- Clinically significant gastrointestinal disorders that may increase the risk of bleeding gastrointestinal.
- Clinically significant gastrointestinal disorders which may affect the absorption of pazopanib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: Pazopanib (GW786034; Votrient®)800 mg / day of pazopanib in monotherapy. | Drug | Pazopanib |
Primary outcome
Objective Response Rate
Time frame: 30 months
To asses the Objective Response (Complete Response or Partial Response) which provides second-line treatment with pazopanib in patients with carcinoma of advanced renal cell who have progressed or have not tolerated a first line of treatment with a Tyrosine Kinase Inhibitor. The Objective Response Rate will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
2 secondary outcomes
Overall Survival
Time frame: 30 months
Treatment Safety Profile
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
Related trials for Metastatic Renal Cell Carcinoma
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)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Joaquim Bellmunt, MD study chair
Hospital del Mar
Marta Guix, MD principal investigator
Hospital del Mar
Juan Manuel Sepúlveda, MD principal investigator
Hospital 12 de Octubre
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Metastatic Renal Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 10 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 16 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Objective Response Rate (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2014.