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Complete title: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating The Efficacy And Safety Of Folfiri + Mehd7945a Versus Folfiri + Cetuximab In Second Line In Patients With Kras Wild-Type Metastatic Colorectal Cancer
|Research Study Number||20121026|
|Principal Investigator||Andrew Coveler, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
Rectal Cancer; Solid Tumors
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