Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 mCRC; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (\>/=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed
Measurable disease per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate hematologic and end-organ function
You may not be if
Prior treatment with irinotecan
Prior treatment with an investigational or approved human epidermal growth factor receptor (HER)-targeted agent
Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1
Leptomeningeal disease as the only manifestation of the current malignancy
Active infection requiring intravenous antibiotics
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
Current severe, uncontrolled systemic disease
Known human immunodeficiency virus (HIV) infection
Untreated/active central nervous system 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
Clareo Health | Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
