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

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The research trial is testing the experimental treatment pimasertib (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 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer.

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

Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II which is a double blind randomized safety/efficacy

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Niacinamide

Criteria

Inclusion Criteria:

For Safety Run-in and Part 2 or Phase 2 Randomised Part

• Histologically confirmed K-Ras mutated colon/rectum cancer

• Subject's disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy with or without bevacizumab

• Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors. Complete tumor assessment performed within 14 days prior to first trial drug administration

• Male/female subjects aged greater than or equal to (>=) 18 years

• Subject has read and understood the informed consent form

• Women of childbearing potential must have a negative blood pregnancy test at the screening visit. Subjects and their partners must be willing to avoid pregnancy during the trial

Exclusion Criteria:

For Safety Run-in and Part 2 or Phase 2 Randomised Part

• Bone marrow impairment

• Renal impairment

• Liver function and liver cell integrity abnormality

• History of central nervous system (CNS) metastases

• History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than (>)1

• Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B

• Has received extensive prior radiotherapy on more than 30 percent (%) of bone marrow reserves, or prior bone marrow/stem cell transplantation

• Has received chemotherapy, any investigational drug, or having participated in another clinical trial within the past 4 weeks prior to trial first drug administration

• Has a history of any other significant medical disease

• Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study

• Has significant cardiac conduction abnormalities and/or pacemaker

• Is a pregnant or nursing female

• Has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion

• Other significant disease that in the Investigator's opinion would exclude the subject from the trial

• Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s)

• Legal incapacity or limited legal capacity