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Temsirolimus and Avastin in Chemotherapy Refractory CRPC
NCT01083368Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2009
- Primary completion
- Dec 2011
- Countries
- 1
- Sponsor
- Case Comprehensive Cancer Center
- Modality
- Small Molecules
- Drugs
- temsirolimus
- Conditions
- castration-resistant prostate cancer (CRPC)
01
Overview
Phase 2, open-label, single-arm trial of temsirolimus in castration-resistant prostate cancer (CRPC), sponsored by Case Comprehensive Cancer Center. Primary endpoints: Maximum Tolerated Dose at 24 weeks and Objective Response Rate at 12 weeks. Started Jan 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Combination of temsirolimus and AVASTIN
Temsirolimus IV weekly + Bevacizumab IV every 2 weeks
03
Who it enrols
Patients with chemotherapy-refractory metastatic CRPC, prior Docetaxel or Mitoxantrone, adequate organ function, and no prior mTOR inhibitors or Avastin.
04
Endpoints
Primary
Maximum Tolerated Dose
Objective Response Rate
Secondary
Time to Clinical Progression
Overall Survival
Toxicity as Assessed by CTCAE v3.0
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