drugset / Trial / NCT02215044

Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT02215044

Phase 1 Terminated 12 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15 every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor marker response in response to the combination of BI 2536 with gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.

Timeline

Start
2007-06
Primary completion
2008-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 2536 Small molecule Intravenous
Background Gemcitabine Small molecule Intravenous

Indications