Subject or subject's legally acceptable representative has provided informed consent.
Male or female >=18 years of age.
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor status.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Measurable or non-measurable disease per RECIST Version 1.1.
Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens for metastatic disease. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ function defined by (<=7 days prior to first dose of study treatment).
Hematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).
Renal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).
Hepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.
Metabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium within normal limits. Serum Potassium within normal limits.
All prior treatment related toxicities common terminology criteria for adverse events (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use adequate contraception, during the study and for 2 months following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use adequate contraception, from time of signing informed consent until 5 months after the last dose of study treatment.

NCT02301962_inc_T2
Person
Male
NCT02301962_inc_T3
Person
female
NCT02301962_inc_T4
Value
>=18 years
NCT02301962_inc_T5
Person
age
NCT02301962_inc_T6
Procedure
Histologically
NCT02301962_inc_T7
Procedure
cytologically
NCT02301962_inc_T8
Value
confirmed
NCT02301962_inc_T9
Condition
adenocarcinoma
NCT02301962_inc_T10
Qualifier
colon
NCT02301962_inc_T11
Qualifier
rectum
NCT02301962_inc_T12
Scope
colon or rectum
NCT02301962_inc_T13
Scope
Histologically or cytologically
NCT02301962_inc_T15
Measurement
Eastern Cooperative Oncology Group (ECOG) performance status
NCT02301962_inc_T16
Value
0, 1 or 2
NCT02301962_inc_T17
Condition
non-measurable disease
NCT02301962_inc_T18
Condition
rable or n se per
NCT02301962_inc_T19
Procedure
RECIST Version 1.1
NCT02301962_inc_T20
Scope
Measurable or non-measurable disease
NCT02301962_inc_T21
Qualifier
failed
NCT02301962_inc_T22
Procedure
pyrimidine-, oxal ning chemotherapy regim
NCT02301962_inc_T23
Procedure
latin-, and ning chemotherapy regim
NCT02301962_inc_T24
Procedure
irinotecan-containing chemotherapy
NCT02301962_inc_T25
Condition
metastatic disease
NCT02301962_inc_T26
Scope
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy
NCT02301962_inc_T27
Condition
disease progression
NCT02301962_inc_T28
Condition
intolerance
NCT02301962_inc_T29
Procedure
the regimen
NCT02301962_inc_T30
Condition
Metastatic relapse
NCT02301962_inc_T31
Temporal
within 6 months after completing adjuvant chemotherapy
NCT02301962_inc_T32
Reference_point
after completing adjuvant chemotherapy
NCT02301962_inc_T33
Procedure
ecan or ox ning regimen) will
NCT02301962_inc_T34
Procedure
oxaliplatin containing regimen
NCT02301962_inc_T35
Scope
irinotecan or oxaliplatin containing regimen
NCT02301962_inc_T36
Condition
Adequate baseline organ function
NCT02301962_inc_T37
Temporal
<=7 days prior to first dose of study treatment
NCT02301962_inc_T38
Reference_point
first dose of study treatment
NCT02301962_inc_T39
Scope
Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen. Metastatic relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease.
NCT02301962_inc_T40
Measurement
Absolute neutrophil count (ANC)
NCT02301962_inc_T41
Value
>=1.5 x 10^9/Liter (L)
NCT02301962_inc_T42
Measurement
Platelet count
NCT02301962_inc_T43
Value
>=75 x 10^9/L
NCT02301962_inc_T44
Measurement
Hemoglobin
NCT02301962_inc_T45
Value
>=8.0 gram/deciliter (g/dL)
NCT02301962_inc_T46
Measurement
Creatinine
NCT02301962_inc_T47
Value
<=1.5 x upper limit of normal (ULN)
NCT02301962_inc_T48
Measurement
spartate aminotransferase (AST)
NCT02301962_inc_T49
Value
<=3 x ULN
NCT02301962_inc_T50
Measurement
Alanine aminotransferase (ALT)
NCT02301962_inc_T51
Value
<=3 x ULN
NCT02301962_inc_T52
Measurement
Total Bilirubin
NCT02301962_inc_T53
Value
<=1.5 x ULN
NCT02301962_inc_T54
Measurement
Serum Magnesium
NCT02301962_inc_T55
Value
within normal limits
NCT02301962_inc_T56
Measurement
Serum Calcium
NCT02301962_inc_T57
Value
within normal limits
NCT02301962_inc_T58
Measurement
Serum Potassium
NCT02301962_inc_T59
Value
within normal limits