NCT01016483

Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer

Phase II Randomized Trial of MEK Inhibitor MSC1936369B or Placebo Combined With Gemcitabine in Metastatic Pancreas Cancer Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts: Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Pimasertib
DRUG	Gemcitabine
DRUG	Placebo

Timeline

• Start date: 2009-11-30
• Primary completion: 2013-12-31
• Completion: 2015-04-30
• First posted: 2009-11-19
• Last updated: 2017-07-13
• Results posted: 2017-06-23

Locations

2 sites across 2 countries: United States, Germany