A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: FOLFIRI; Drug: RO5083945; Drug: cetuximab

• Registration Number: NCT01326000
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KRAS mutant B	FOLFIRI	-
KRAS WT A	FOLFIRI	-
KRAS WT A	RO5083945	-
KRAS WT B	FOLFIRI	-
KRAS mutant A	FOLFIRI	-
KRAS mutant A	RO5083945	-
KRAS WT B	cetuximab	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival: tumour assessments by CT scan or MRI according to RECIST criteria	approximately 18 months

Secondary Outcome Measures

Name	Time	Method
Effect of concomitant FOLFIRI on pharmacokinetics of RO5083945 and vice versa	approximately 18 months
Overall survival	approximately 18 months
Safety: Incidence of adverse events	approximately 18 months
Overall Response Rate: tumour assessments by CT scan or MRI according to RECIST criteria	approximately 18 months
Duration of response: time from complete or partial response to disease progression or death	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	approximately 18 months