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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01152437

First received: June 28, 2010

Last updated: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2010

Last Updated Date

September 18, 2012

Start Date ^ICMJE

June 2010

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01152437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Colorectal Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01152437

Other Study ID Numbers ^ICMJE

1200.74, 2009-011996-59

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

September 2012

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

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