MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)

Metastatic Colorectal Cancer Clinical Trial

Official title: A Double-blind, Randomized, Comparative, Multicenter, Exploratory, and Placebo-controlled Phase II Trial of FOLFIRI Plus MSC1936369B or Placebo With a Safety run-in Part as Second-line Treatment of Metastatic K Ras Mutated Colorectal Cancer Subjects

Status Completed

Clinical Trial Summary

The research trial is testing the experimental treatment MSC1936369B in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. The study will be run in two parts:

Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended Phase II dose (RP2D) of MSC1936369B combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer.

Part 2 or Phase II Randomised Part: Will assess the anti-tumor activity of MSC1936369B combined with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras mutated colorectal cancer subjects.

Clinical Trial Description

Part 1 or Safety Run-in Part: Single Arm Masking: Open Allocation: N/A

Part 2 or Phase II Randomised Part: 2 Arms Masking: Double Blind - Subject is blinded, Caregiver is blinded, Investigator is blinded and Outcomes Assessor is blinded Allocation: Randomized ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT01085331
• Study type: Interventional
• Source: EMD Serono
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2010
• Completion date: April 2012