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
Description
Brief Summary
This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy
of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU],
and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with
Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after
first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be
randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated
time on study treatment is until disease progression or unacceptable toxicity occurs.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- 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
- 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
Sites
-
California
- Unknown facility, Los Angeles, California, 90033
- Unknown facility, Los Angeles, California, 90095
- Unknown facility, Fullerton, California, 92835
- Unknown facility, Santa Barbara, California, 93105
- Unknown facility, Bakersfield, California, 93309
- Unknown facility, San Luis Obispo, California, 93454
- Unknown facility, San Luis Obispo, California, 93454
-
Nevada
- Unknown facility, Las Vegas, Nevada, 89148
- Unknown facility, Las Vegas, Nevada, 89148
-
Colorado
- Unknown facility, Aurora, Colorado, 80045
- Unknown facility, Aurora, Colorado, 80045
-
Washington
- Unknown facility, Seattle, Washington, 98109
- Unknown facility, Kirkland, Washington, 98034
-
Missouri
- Unknown facility, Jefferson City, Missouri, 65109
-
Kentucky
- Unknown facility, Paducah, Kentucky, 42003
-
Illinois
- Unknown facility, Harvey, Illinois, 60426
-
France
- Unknown facility, Villejuif, 94805
- Unknown facility, Paris, 75015
-
Germany
- Unknown facility, Stuttgart, 70199
- Unknown facility, Stuttgart, 70199
-
Veneto
- Unknown facility, Padova, Veneto, 35128
Powered by
SC CTSI