A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum,
with KRAS wild-type status
- Progressive disease on or after first-line oxaliplatin-containing regimen for
metastatic colorectal cancer; patients must have received oxaliplatin-containing
chemotherapy for >/= 3 months; no more than one prior chemotherapy for metastatic
disease is allowed
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic and end-organ function
Exclusion Criteria:
- Prior treatment with irinotecan
- Prior treatment with an investigational or approved HER-targeted agent
- Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1, including
chemotherapy, biologic, experimental, hormonal or radiotherapy, or not having
recovered from all treatment-related toxicities (except for alopecia) to Grade =1,
with the following exceptions: oxaliplatin-containing chemotherapy within 2
weeks prior to Cycle 1, Day 1, oxaliplatin-related neuropathy that is Grade = 2 and
considered stable, and palliative radiotherapy to bone metastases within 2 weeks
prior to Cycle 1, Day 1
- Leptomeningeal disease as the only manifestation of the current malignancy
- Active infection requiring IV antibiotics
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory
drugs
- Current severe , uncontrolled systemic disease
- History of cardiac heart failure or serious cardiac arrhythmia requiring treatment
(except for atrial fibrillation and paroxysmal supraventricular tachycardia)
- History of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history
of unstable angina
- Clinically significant GI bleeding within 6 months prior to Cycle 1 Day 1
- History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic
antibodies that required discontinuation of treatment
- Known HIV infection
- Untreated CNS metastases (progressing or requiring anticonvulsants or corticosteroids
for symptomatic control)
- Pregnant or lactating women
- Malignancies other than colorectal cancer within 5 years prior to randomization,
except for adequately treated basal or squamous cell skin cancer and carcinoma in
situ of the cervix