Carcinoma, Renal CellPhase 2NCT00835978
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
A Phase 2 study testing axitinib in people with Carcinoma, Renal Cell, run by Pfizer at 65 sites in 6 countries.
Trial summary
Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 65 sitesin 6 countries
- Study dates
- Aug 2009to Feb 2016
- Phase
- Phase 2
- 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
Who may be able to join
- metastatic renal cell carcinoma (kidney cancer) with clear cell component
- no prior systemic therapy (including no prior adjuvant or neoadjuvant)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Blood Pressure < or = 140/90mmHg
Who cannot join
- brain/CNS metastasis
- using more than 2 blood pressure medications
Trial locations and contacts
65 sites in 6 countries.
65 sites in 6 countries
United States31 sites
East Bay Medical Oncology/Hematology Medical Associates Inc.
Antioch, California, 94531
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The University Hospital
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University, James Cancer Hospital
Columbus, Ohio, 43210
JamesCare in Kenny
Columbus, Ohio, 43221
Texas Oncology, Sammons Cancer Center
Dallas, Texas, 75246
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4004
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Investigational Drug Services, IUHSCC
Indianapolis, Indiana, 46202
IU Health University Hospital
Indianapolis, Indiana, 46202
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523
Diablo Valley Oncology and Hematology Medical Group Inc
Pleasant Hill, California, 94523
East Bay Medical Oncology/Hematology Medical Associates Inc
Pleasant Hill, California, 94523
Oregon Health and Science University
Portland, Oregon, 97239
East Bay Medical Oncology/Hematology Medical Associates Inc
San Leandro, California, 94578
Virginia Mason Medical Center
Seattle, Washington, 98101
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094
Washington University
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
West Chester Hospital Medical Building
West Chester, Ohio, 45069
Japan15 sites
Akita University Hospital
Akita, 010-8543
Chiba Cancer Center
Chiba, 260-8717
National Cancer Center
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka, 812-8582
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Japanese Foundation For Cancer Research Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550
Nagasaki University Hospital
Nagasaki, 852-8501
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8638
Kinki University Hospital
Sayama, Osaka, 589-8511
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Tokushima University Hospital
Tokushima, 770-8503
Yamagata University Hospital
Yamagata, 990-9585
Russia7 sites
FSBSI "N.N. Blokhin Russian Cancer Research Center"
Moscow, 115478
FSBI"Russian Scientific Center of Roengenoradiology" of the MH of RF
Moscow, 117997
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Obninsk, Kaluga Oblast, 249036
State Healthcare Institution "Leningrad Regional Oncology Dispensary"
Poselok Kuzmolovskiy, Vsevolozhskiy Region, Leningradskaya Oblast, 188663
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
Saint Petersburg, 197022
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
Saint Petersburg, 198255
GBUZ "Samara Regional Clinical Oncology Dispensary"
Samara, 443031
Germany5 sites
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt, 60590
Medizinische Hochschule Hannover, Abt. Haematologie, Haemostaseologie & Onkologie
Hanover, 30625
Eberhardt-Karls-Universitaet Tuebingen, Klinik fuer Urologie
Tübingen, 72076
Klinikum Weiden Klinik fuer Urologie, Andrologie und Kinderurologie
Weiden, 92637
Czechia4 sites
Masarykuv onkologicky ustav
Brno, CZE, 656 53
Fakultni nemocnice Olomouc Onkologicka klinika
Olomouc, 775 20
Fakultni nemocnice Na Bulovce
Prague, 180 81
Krajska zdravotni, a.s. - Masarykova nemocnice V Usti nad Labem, o.z.
Ústí nad Labem, 401 13
Spain3 sites
Hospital de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario La Paz
Madrid, 28046
About this study
Official title: Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- axitinib
- Keywords
- axitinib or AG-013736 dose titration (increase) renal cell carcinoma, kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axitinibDrug
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
axitinibDrug
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
axitinibDrug
axitinib 5mg BID (open-label)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Randomized arm Receives: Drug: axitinib |
| B | Other | Randomized arm Receives: Drug: axitinib |
| C | Other | Non-randomized arm Receives: Drug: axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) - Percentage of Participants With Objective Response
ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
Secondary outcomes (18)
Progression-Free Survival (PFS)
The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.
Measured: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
Duration of Response (DR)
DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.
Measured: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
Overall Survival (OS)
OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.
Measured: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
Maximum Observed Plasma Concentration (Cmax) of Axitinib
Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.
Measured: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,
Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib
Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib
Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Plasma Decay Half-Life (t1/2) for Axitinib
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Oral Clearance (CL/F) of Axitinib
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.
Measured: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Change From Baseline in Systolic Blood Pressure
Value at respective visit minus value at baseline
Measured: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
Change From Baseline in Diastolic Blood Pressure
Value at respective visit minus value at baseline.
Measured: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.
Measured: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.
Measured: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.
Measured: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline
CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.
Measured: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.
Measured: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.
Measured: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2012
- Study completionFeb 2016
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835978
- Sponsor's protocol ID
- A4061046
- Other IDs
- 2008-007786-23, 2008
- Status last verified
- Apr 2017
- First submitted
- 2 Feb 2009
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tomita Y, Uemura H, Oya M, Shinohara N, Habuchi T, Fujii Y, Kamei Y, Umeyama Y, Bair AH, Rini BI. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study. BMC Cancer. 2019 Jan 7;19(1):17. doi: 10.1186/s12885-018-5224-6.
PubMed 30616534de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
PubMed 28410911Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
PubMed 27238653Rini BI, Melichar B, Ueda T, Grunwald V, Fishman MN, Arranz JA, Bair AH, Pithavala YK, Andrews GI, Pavlov D, Kim S, Jonasch E. Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial. Lancet Oncol. 2013 Nov;14(12):1233-42. doi: 10.1016/S1470-2045(13)70464-9. Epub 2013 Oct 18.
PubMed 24140184
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00835978
- Acronym / sponsor ID
- A4061046
- Conditions
- Carcinoma, Renal Cell
- Keywords
- axitinib or AG-013736 dose titration (increase) renal cell carcinoma, kidney cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: axitinibRandomized arm |
| B | Other | Drug: axitinibRandomized arm |
| C | Other | Drug: axitinibNon-randomized arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- metastatic renal cell carcinoma (kidney cancer) with clear cell component
- no prior systemic therapy (including no prior adjuvant or neoadjuvant)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Blood Pressure < or = 140/90mmHg
Key exclusion criteria (2 listed)
- brain/CNS metastasis
- using more than 2 blood pressure medications
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 |
|---|---|---|
| axitinibaxitinib 5mg BID (open-label) + axitinib dose titration (blinded) | Drug | A |
| axitinibaxitinib 5mg BID (open-label) + placebo dose titration (blinded) | Drug | B |
| axitinibaxitinib 5mg BID (open-label) | Drug | C |
Primary outcome
Objective Response Rate (ORR) - Percentage of Participants With Objective Response
Time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
18 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
Duration of Response (DR)
Time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks
Overall Survival (OS)
Time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
Maximum Observed Plasma Concentration (Cmax) of Axitinib
Time frame: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Plasma Decay Half-Life (t1/2) for Axitinib
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Oral Clearance (CL/F) of Axitinib
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib
Time frame: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Change From Baseline in Systolic Blood Pressure
Time frame: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
Change From Baseline in Diastolic Blood Pressure
Time frame: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline
Time frame: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline
Time frame: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+
Time frame: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline
Time frame: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
Time frame: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
Time frame: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30616534Tomita Y, Uemura H, Oya M, Shinohara N, Habuchi T, Fujii Y, Kamei Y, Umeyama Y, Bair AH, Rini BI. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study. BMC Cancer. 2019 Jan 7;19(1):17. doi: 10.1186/s12885-018-5224-6.
- Derived from this study: PubMed 28410911de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Derived from this study: PubMed 27238653Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Derived from this study: PubMed 24140184Rini BI, Melichar B, Ueda T, Grunwald V, Fishman MN, Arranz JA, Bair AH, Pithavala YK, Andrews GI, Pavlov D, Kim S, Jonasch E. Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial. Lancet Oncol. 2013 Nov;14(12):1233-42. doi: 10.1016/S1470-2045(13)70464-9. Epub 2013 Oct 18.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Carcinoma, Renal Cell
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
RecruitingPhase 3
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Carcinoma, Renal Cell
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
65 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing axitinib in people with Carcinoma, Renal Cell, run by Pfizer at 65 sites in 6 countries.
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 2 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Japan, Russia, Germany, Czechia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 26 May 2014). 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?
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (time frame: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.). 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 NCT00835978, which also lists 4 linked publications.
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 30 May 2017.