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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter \[mg/m\^2\] administered as intravenous bolus and then 5-FU 2400 mg/m\^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Cetuximab 400 mg/m\^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m\^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity.
Standard Irinotecan chemotherapy (180 milligram per square meter \[mg/m\^2\] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
Standard Leucovorin chemotherapy (400 mg/m\^2 \[racemic form\] or 200 mg/m\^2 \[L-isomer form\] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.
Unnamed facility
Bakersfield, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Luis Obispo, California, United States
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Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria
Time frame: approximately 2 year
Plasma Concentration of 5-Fluorouracil
Time frame: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4
Plasma Concentration of Irinotecan
Time frame: Pre-dose, 1 hour and after end of infusion on Day 1 Cycles 1-4
Number of Participants With Anti-MEHD7945A Antibodies
Time frame: Pre-dose on Day 1 Cycles 1, 4, and 8; treatment completion visit (up to approximately 2 years)
Number of Participants With Objective Response According to Modified RECIST v1.1 Criteria
Time frame: approximately 2 year
Duration of Objective Response According to Modified RECIST v1.1 Criteria
Time frame: approximately 2 year
Overall Survival (OS)
Time frame: approximately 2 year
Number of Participants With Adverse Events
Time frame: approximately 2 year
Maximum Observed Serum Concentration (Cmax) of MEHD7945A
Time frame: Pre-dose and 30 minutes after end of infusion on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year)
Minimum Observed Serum Concentration (Cmin) of MEHD7945A
Time frame: Pre-dose on Day 1 Cycles 1-4, Cycle 8 and at treatment completion (up to approximately 2 year)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Santa Barbara, California, United States
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Aurora, Colorado, United States
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Orange Park, Florida, United States
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Harvey, Illinois, United States
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Paducah, Kentucky, United States
...and 55 more locations