Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
1 other identifier
interventional
62
1 country
5
Brief Summary
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
April 3, 2012
CompletedJuly 31, 2012
July 1, 2012
2.9 years
January 23, 2006
February 25, 2012
July 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Secondary Outcomes (5)
Progression-free Survival (PFS)
Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks
Duration of Response (DR)
Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Overall Survival (OS)
Baseline to death due to any cause or at least 1 year after the first dose for the last participant
Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score
Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Population Pharmacokinetics of Axitinib (AG-013736)
Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Other Outcomes (4)
Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) Score
Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)
Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)
Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
- +1 more other outcomes
Study Arms (1)
AG-013736 (axitinib)
EXPERIMENTALAG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
Interventions
AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.
Eligibility Criteria
You may qualify if:
- RCC with metastases and nephrectomy
- failure of prior sorafenib-based therapy
- at least 1 target lesion that has not been irradiated
- adequate bone marrow, hepatic and renal function, \> or equal to 18 years of age.
You may not qualify if:
- Gastrointestinal abnormalities
- current use or inability to avoid chronic antacid therapy
- current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
- active seizure disorder or evidence of brain metastases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Pfizer Investigational Site
Chicago, Illinois, 60637, United States
Pfizer Investigational Site
The Bronx, New York, 10466, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111-2497, United States
Pfizer Investigational Site
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2006
First Posted
January 25, 2006
Study Start
March 1, 2006
Primary Completion
February 1, 2009
Study Completion
June 1, 2009
Last Updated
July 31, 2012
Results First Posted
April 3, 2012
Record last verified: 2012-07