A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01152437
First received: June 28, 2010
Last updated: October 29, 2013
Last verified: October 2013

June 28, 2010
October 29, 2013
June 2010
March 2012   (final data collection date for primary outcome measure)
  • Percentage of Participants With Objective Response [ Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
Objective response (complete response, partial response) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01152437 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months ] [ Designated as safety issue: No ]
    PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.
  • Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) [ Time Frame: day 8 ] [ Designated as safety issue: No ]
    Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
  • 1. Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 2. Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 3. Safety and tolerability of BIBW 2992 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 4. Exploratory analysis of biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 5. Pharmacokinetic analysis of BIBW 2992 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
  • Drug: BIBW 2992
    Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
  • Drug: Cetuximab
    Patients receive cetuximab intravenously, once a week, every week
  • Experimental: BIBW 2992
    Patients receive BIBW 2992 tablets once daily
    Intervention: Drug: BIBW 2992
  • Active Comparator: Cetuximab
    Patients receive cetuximab intravenously once a week, every week
    Intervention: Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
Not Provided
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01152437
1200.74, 2009-011996-59
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP