This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
169
standard iv chemotherapy
1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
Unnamed facility
Encinitas, California, United States
Unnamed facility
Highland, California, United States
Unnamed facility
La Jolla, California, United States
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La Verne, California, United States
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Los Angeles, California, United States
Unnamed facility
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Time frame: approximately 18 months
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria
Time frame: approximately 18 months
Duration of response: time from complete or partial response to disease progression or death
Time frame: approximately 18 months
Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria
Time frame: approximately 18 months
Overall survival
Time frame: approximately 18 months
Safety: Incidence of adverse events
Time frame: approximately 18 months
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa
Time frame: approximately 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
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Harvey, Illinois, United States
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Skokie, Illinois, United States
Unnamed facility
Skokie, Illinois, United States
...and 59 more locations