drugset / Trial / NCT01374789
PURO Panitumumab in Combination With Gemcitabine/Cisplatin in Advanced Urothelial Cancer
Phase 2
Terminated
2 enrolled
WiSP Wissenschaftlicher Service Pharma GmbH
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to assess the efficacy of the combination consisting of gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.
Timeline
- Start
- 2010-07
- Primary completion
- 2012-03
- Completion
- 2012-03
Outcome
Outcome not reported
Stopped (Enrollment): “The study was terminated due to insufficient recruitment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 9 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |