PURO - An Open-label, Randomised, Multicentre, Phase II Study to Evaluate the Efficacy of Chemotherapy With Gemcitabine and Cisplatin in Combination With the EGF Receptor Antibody Panitumumab (GemCisP) Versus GemCis in the First-line Therapy of Locally Advanced/Metastatic Urothelial Carcinoma in Patients With Wild-type HRAS

NCT01374789 Phase 2 TERMINATED

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.

Details

Lead sponsor	WiSP Wissenschaftlicher Service Pharma GmbH
Phase	Phase 2
Status	TERMINATED
Enrolment	2
Start date	2010-07
Completion	2012-03

Conditions

• Urinary Bladder Cancer

Interventions

• GemCis + Panitumumab
• GemCis

Primary outcomes

• Primary end point: Progression-free survival rate after 12 months. — 12 months

Countries

Germany