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Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

Primary Purpose

Carcinoma, Renal Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
axitinib
axitinib
axitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring axitinib or AG-013736 dose titration (increase) renal cell carcinoma, kidney cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • brain/CNS metastasis
  • using more than 2 blood pressure medications

Sites / Locations

  • East Bay Medical Oncology/Hematology Medical Associates Inc.
  • Comprehensive Blood and Cancer Center
  • Bay Area Cancer Research Group, LLC
  • Diablo Valley Oncology and Hematology Medical Group Inc
  • East Bay Medical Oncology/Hematology Medical Associates Inc
  • East Bay Medical Oncology/Hematology Medical Associates Inc
  • H. Lee Moffitt Cancer Center and Research Institute
  • Indiana University Melvin and Bren Simon Cancer Center
  • Investigational Drug Services, IUHSCC
  • IU Health University Hospital
  • University of Maryland Greenebaum Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Cancer and Hematology Centers of Western Michigan
  • Barnes-Jewish Hospital
  • Washington University
  • Nebraska Methodist Hospital
  • University of Nebraska Medical Center
  • Nevada Cancer Institute
  • The University Hospital
  • University of Cincinnati
  • Cleveland Clinic
  • The Ohio State University, James Cancer Hospital
  • JamesCare in Kenny
  • West Chester Hospital Medical Building
  • Oregon Health and Science University
  • Texas Oncology, Sammons Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • Virginia Mason Medical Center
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc Onkologicka klinika
  • Fakultni nemocnice Na Bulovce
  • Krajska zdravotni, a.s. - Masarykova nemocnice V Usti nad Labem, o.z.
  • Universitaetsklinikum Duesseldorf
  • Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
  • Medizinische Hochschule Hannover, Abt. Haematologie, Haemostaseologie & Onkologie
  • Eberhardt-Karls-Universitaet Tuebingen, Klinik fuer Urologie
  • Klinikum Weiden Klinik fuer Urologie, Andrologie und Kinderurologie
  • Nagoya University Hospital
  • Sapporo Medical University Hospital
  • Hokkaido University Hospital
  • Kobe University Hospital
  • Kinki University Hospital
  • Hamamatsu University School of Medicine, University Hospital
  • National Cancer Center
  • Japanese Foundation For Cancer Research Cancer Institute Hospital
  • Keio University Hospital
  • Akita University Hospital
  • Chiba Cancer Center
  • Kyushu University Hospital
  • Nagasaki University Hospital
  • Tokushima University Hospital
  • Yamagata University Hospital
  • Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
  • State Healthcare Institution "Leningrad Regional Oncology Dispensary"
  • FSBSI "N.N. Blokhin Russian Cancer Research Center"
  • FSBI"Russian Scientific Center of Roengenoradiology" of the MH of RF
  • Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
  • Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
  • GBUZ "Samara Regional Clinical Oncology Dispensary"
  • Hospital de La Princesa
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

A

B

C

Arm Description

Randomized arm

Randomized arm

Non-randomized arm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,
Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.
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.
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.
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.
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.
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.
Change From Baseline in Systolic Blood Pressure
Value at respective visit minus value at baseline
Change From Baseline in Diastolic Blood Pressure
Value at respective visit minus value at baseline.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 2, 2009
Last Updated
April 18, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00835978
Brief Title
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Official Title
Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
axitinib or AG-013736 dose titration (increase) renal cell carcinoma, kidney cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Randomized arm
Arm Title
B
Arm Type
Other
Arm Description
Randomized arm
Arm Title
C
Arm Type
Other
Arm Description
Non-randomized arm
Intervention Type
Drug
Intervention Name(s)
axitinib
Intervention Description
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
Intervention Type
Drug
Intervention Name(s)
axitinib
Intervention Description
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
Intervention Type
Drug
Intervention Name(s)
axitinib
Intervention Description
axitinib 5mg BID (open-label)
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) - Percentage of Participants With Objective Response
Description
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.
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.
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
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.
Title
Duration of Response (DR)
Description
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.
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
Title
Overall Survival (OS)
Description
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.
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.
Title
Maximum Observed Plasma Concentration (Cmax) of Axitinib
Description
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.
Time Frame
Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,
Description
Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib
Description
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.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib
Description
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.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Plasma Decay Half-Life (t1/2) for Axitinib
Description
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.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Apparent Oral Clearance (CL/F) of Axitinib
Description
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.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib
Description
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.
Time Frame
C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose
Title
Change From Baseline in Systolic Blood Pressure
Description
Value at respective visit minus value at baseline
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.
Title
Change From Baseline in Diastolic Blood Pressure
Description
Value at respective visit minus value at baseline.
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.
Title
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline
Description
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.
Time Frame
At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Title
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline
Description
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.
Time Frame
At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
Title
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+
Description
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.
Time Frame
At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Title
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline
Description
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.
Time Frame
At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)
Title
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
Description
ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.
Time Frame
At baseline - Beginning of the lead-in period (Cycle 1 Day 1)
Title
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms
Description
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.
Time Frame
At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: brain/CNS metastasis using more than 2 blood pressure medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
East Bay Medical Oncology/Hematology Medical Associates Inc.
City
Antioch
State/Province
California
ZIP/Postal Code
94531
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Diablo Valley Oncology and Hematology Medical Group Inc
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
East Bay Medical Oncology/Hematology Medical Associates Inc
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
East Bay Medical Oncology/Hematology Medical Associates Inc
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Drug Services, IUHSCC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University, James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
JamesCare in Kenny
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
West Chester Hospital Medical Building
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Texas Oncology, Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4004
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Masarykuv onkologicky ustav
City
Brno
State/Province
CZE
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc Onkologicka klinika
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice V Usti nad Labem, o.z.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Abt. Haematologie, Haemostaseologie & Onkologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Eberhardt-Karls-Universitaet Tuebingen, Klinik fuer Urologie
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum Weiden Klinik fuer Urologie, Andrologie und Kinderurologie
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kinki University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu-City
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
National Cancer Center
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Japanese Foundation For Cancer Research Cancer Institute Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
City
Obninsk
State/Province
Kaluga Region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Healthcare Institution "Leningrad Regional Oncology Dispensary"
City
Poselok Kuzmolovskiy
State/Province
Vsevolozhskiy Region, Leningradskaya Oblast
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
FSBSI "N.N. Blokhin Russian Cancer Research Center"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FSBI"Russian Scientific Center of Roengenoradiology" of the MH of RF
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
GBUZ "Samara Regional Clinical Oncology Dispensary"
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Hospital de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30616534
Citation
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.
Results Reference
derived
PubMed Identifier
28410911
Citation
de 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.
Results Reference
derived
PubMed Identifier
27238653
Citation
Grunwald 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.
Results Reference
derived
PubMed Identifier
24140184
Citation
Rini 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. Erratum In: Lancet Oncol. 2014 Jun;15(7):e253.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061046&StudyName=Axitinib%20%28AG-013736%29%20With%20Or%20Without%20Dose%20Titration%20%28Increase%29%20In%20Patients%20With%20Kidney%20Cancer
Description
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Learn more about this trial

Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

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