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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms
Both
Colorectal Neoplasms
Trial Information
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
Inclusion Criteria
Inclusion criteria:
1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and
irinotecan-based regimens
2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene
homolog) mutation testing and other biomarker analyses.
Exclusion criteria:
1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small
molecules or antibodies.
2. Biological treatment (including Bevacizumab or any other antiangiogenic agents)
during the trial is not allowed.
3. Known pre-existing interstitial lung disease.
4. Planned major surgical procedures during the trial period.
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:
Objective response (complete response, partial response) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Boehringer Ingelheim
Investigator Role:
Study Chair
Investigator Affiliation:
Boehringer Ingelheim Pharmaceuticals
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
1200.74
NCT ID:
NCT01152437
Start Date:
June 2010
Completion Date:
Related Keywords:
- Colorectal Neoplasms
- Neoplasms
- Colorectal Neoplasms
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