Clinical trial NCT01085331 (phase 1/phase 2, status: terminated)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: pimasertib, placebo, folfiri
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, FC1=CNC(=O)NC1=O
Reason stopped: 
    conduct the randomized phase 2 part not recommended due to the achieved mtd for pimasertib
    (45mg/day) in combination with folfiri
  
Eligibility 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