Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)
