drugset / Trial / NCT00710710

Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer

NCT00710710

Phase 2 Completed 89 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.

Timeline

Start
2006-08-01
Primary completion
2008-10-14
Completion
2008-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 2536 Small molecule 60 mg Intravenous
Subject BI 2536 Small molecule 200 mg Intravenous

Indications