A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Carcinoma of the colon and/or rectum
- Disease progression during or within 6 months of last dose of oxaliplatin containing
first-line combination therapy for metastatic disease
- ECOG performance status 0-1
- Adequate hematological, renal and liver function
Exclusion Criteria:
- Prior treatment with monoclonal antibody/small molecule against epidermal growth
factor receptor (EGFR)
- Prior treatment with irinotecan
- Radiotherapy within the last 4 weeks before first dose of study drug (except for
limited field palliative radiotherapy for bone pain relief)
- CNS metastasis
- History of or active autoimmune disorders/conditions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria
Outcome Time Frame:
approximately 18 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
BP25438
NCT ID:
NCT01326000
Start Date:
April 2011
Completion Date:
August 2013
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Fountain Valley, California 92708 | |
| Philadelphia, Pennsylvania 19104 | |
| Omaha, Nebraska 68114 | |
| Charlotte, North Carolina | |
| Charleston, South Carolina |
