An Open Label, Partially Randomised Phase II Study to Investigate the Efficacy and Safety of BIBW 2992 in Patients With Metastatic Colorectal Cancer Who Never Received Prior Anti-EGFR (Epidermal Growth Factor Receptor) Treatment
Overview
- Phase
- Phase 2
- Intervention
- BIBW 2992
- Conditions
- Colorectal Neoplasms
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 94
- Locations
- 13
- Primary Endpoint
- Percentage of Participants With Objective Response
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BIBW 2992
Patients receive BIBW 2992 tablets once daily
Intervention: BIBW 2992
Cetuximab
Patients receive cetuximab intravenously once a week, every week
Intervention: Cetuximab
Outcomes
Primary Outcomes
Percentage of Participants With Objective Response
Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
Percentage of Participants With Disease Control (DC)
Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
Secondary Outcomes
- Progression Free Survival (PFS)(Baseline till progression or death, whichever came first, assessed up to 23 months)
- Overall Survival (OS) Time(Baseline till death, assessed up to 23 months)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)(day 8)