Health Condition 1: null- Advanced Renal Cell Carcinoma
Conditions
Interventions
Intervention1: Bevacizumab + Temsirolimus: 10 mg/kg bevacizumab IV once every other week + 25 mg temsirolimus IV once weekly. On the weeks that bevacizumab is given, it will be given prior to temsirol
Sponsors
Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC) 2. Majority component of conventional clear-cell type is mandatory 3. At least 1 measurable lesion (per RECIST) Please note: there is no upper age limit for inclusion criteria for this trial
Exclusion criteria
Exclusion criteria: 1. Prior systemic treatment for RCC 2. Evidence of current or prior central nervous system (CNS) metastases 3. Cardiovascular disease 4. Pregnant or nursing women 5. Additional criteria applies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Independently assessed progression free survival (PFS)Timepoint: every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed progression free survival (PFS), objective response rateTimepoint: Every 8 weeks;SafetyTimepoint: evey 4 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
Representing Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.)
Outcome results
None listed