Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Phase 3
- Conditions
- Health Condition 1: null- Kidney Neoplasms
- Registration Number
- CTRI/2009/091/000565
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 650
Inclusion Criteria
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
1. Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis .
2.Evidence of measurable disease
3.Must have failed one prior systemic first-line regimen for metastatic renal cell cancer
Kindly note that there is no upper age limit for inclusion criteria for this trial
Exclusion Criteria
1. Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
2. Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free SurvivalTimepoint: 3 years
- Secondary Outcome Measures
Name Time Method Duration of Response in Each ArmTimepoint: 3 Years;Kidney Specific Symptoms tested by Functional Assessment of Cancer Therapy Kidney Symptom Index [FKSI] and Health Status EQ-5D [European Quality of Life Scale]Timepoint: 3 Years <br/ ><br> <br/ ><br>;Overall SurvivalTimepoint: 3 years;Response RateTimepoint: 3 years;Safety and Tolerability on Axitinib: number of patients with metastatic renal cell cancer with incidence of drug related adverse eventsTimepoint: 3 Years