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.
- Conditions
- Metastatic colorectal cancer, KRAS wild-type (WT) or mutant, with disease progression after first line treatment with an oxaliplatin-containing regimen.MedDRA version: 12.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic
- Registration Number
- EUCTR2010-022983-11-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 169
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method