Metastatic colorectal cancer, KRAS wild-type (WT) or mutant, with disease progression after first line treatment with an oxaliplatin-containing regimen MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: GA201
Product Code: RO5083945
Pharmaceutical Form: Solution for infusion
CAS Number: 959963-46-3
Current Sponsor code: RO5083945
Other descriptive name: huMab (GA201)
Concentration unit:
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to gather preliminary evidence of superior activity, of RO5083945 added to FOLFIRI versus FOLFIRI + cetuximab in terms of progression free survival (PFS) in patients with KRAS WT colorectal cancer • to gather preliminary evidence of superior activity, of RO5083945 added to FOLFIRI versus FOLFIRI alone in terms of progression free survival (PFS) in patients with KRAS mutant colorectal cancer;Secondary Objective: • to evaluate best overall response rate (ORR) • to evaluate duration of response • to evaluate clinical benefit rate (CBR) • to evaluate overall survival • to evaluate the safety profile of patients treated with RO5083945 in combination with FOLFIRI versus FOLFIRI + cetuximab or FOLFIRI alone • to assess the effect of concomitant FOLFIRI on the pharmacokinetics of RO5083945 and vice versa • to evaluate the relationship between immune effector cells (in blood and tumor) and clinical outcome parameters (e.g. responders vs. non responders, PFS) • to evaluate the relationship between key upstream (e.g. ligands) and downstream EGFR markers (in tumor) and clinical outcome parameters (e.g. responders vs. non responders, PFS) • to compare fresh (new) vs. archival tumor biopsies (e.g. for EGFR expression);Primary end point(s): The primary variable is PFS defined as the time between randomization and date of first documented disease progression or death, whichever occurs first.;Timepoint(s) of evaluation of this end point: 6 months after LPI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria - Duration of response: time from complete or partial response to disease progression or death - Clinical benefit rate: stable disease for >6 weeks, complete response or partial response; tumour assessments by CT scan or MRI according to RECIST criteria - Overall survival - Incidence of adverse events - Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa;Timepoint(s) of evaluation of this end point: 6 months after LPI | — |
Countries
Australia, Belgium, France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed