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
Inclusion Criteria:
For Safety Run-in and Phase II:
1. Histologically confirmed K-Ras mutated colon/rectum cancer.
2. 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.
3. 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.
4. Male / female subjects aged greater or equal to 18 years.
5. Subject has read and understood the Informed Consent Form.
6. 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 Phase II:
1. Bone marrow impairment
2. Renal impairment
3. Liver function and liver cell integrity abnormality
4. History of central nervous system (CNS) metastases
5. History of difficulty of swallowing, malabsorption or other chronic gastrointestinal
disease
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.
7. Known HIV positivity, active hepatitis C, or active hepatitis B.
8. Has received extensive prior radiotherapy on more than 30% of bone marrow reserves,
or prior bone marrow/stem cell transplantation
9. Has received chemotherapy, any investigational drug, or having participated in an
other clinical trial within the past 4 weeks prior to trial first drug
administration.
10. Has a history of any other significant medical disease
11. Past or current history (within the last 2 years prior to inclusion) of malignancies
except for the indication under this study
12. Has significant cardiac conduction abnormalities and/or pacemaker.
13. Is a pregnant or nursing female.
14. Has retinal degenerative disease, history of uveitis, or history of retinal vein
occlusion.
15. Other significant disease that in the Investigator's opinion would exclude the
subject from the trial.
16. Known hypersensitivity to the trial treatment(s) or diluents (when applicable),
including placebo or other comparator drug(s).
17. Legal incapacity or limited legal capacity