Phase 2
N=94
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01152437 ↗Enrolled (actual)
94
Serious AEs
41.8%
Results posted
Nov 2013
Primary outcome: Primary: Percentage of Participants With Objective Response — 3; 20 Percentage of Participants — p=0.0735
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIBW 2992 (Drug); Cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response |
3; 20 | 0.0735 |
| PRIMARY Percentage of Participants With Disease Control (DC) |
12 | 0.6394 |
| SECONDARY Progression Free Survival (PFS) |
46.0; 144.5; 41.0 | — |
| SECONDARY Overall Survival (OS) Time |
355.0; NA; 173.0 | — |
| SECONDARY Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) |
16.6; 21.4 | — |
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.
Eligibility Criteria
Inclusion criteria
- Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
- Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
Exclusion criteria
- Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
- Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
- Known pre-existing interstitial lung disease.
- Planned major surgical procedures during the trial period.
Data sourced from ClinicalTrials.gov (NCT01152437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.