Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
- Conditions
- Health Condition 1: null- Kidney Neoplasms
- Registration Number
- CTRI/2010/091/000619
- 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
- 0
1. Ages Eligible for Study:18 Years and older,
2. Genders Eligible for Study:Both,
3. Accepts Healthy Volunteers:No,
4. Histologically documented metastatic renal cell cancer with a component of clear cell histology.
5. Evidence of measurable disease.
6. Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
The upper age limit is not defined in the protocol.
-Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
-Major surgery less that 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 and Health StatusTimepoint: 3 years;Overall SurvivalTimepoint: 3 years;Response RateTimepoint: 3 Years;Safety and Tolerability on AxitinibTimepoint: 3 Years