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

NCT01152437 | Completed Phase 2 Results

• 2 other identifiers: 1200.742009-011996-59
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 13

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Objective Response

  Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.

  Baseline till progression or death, whichever came first, assessed up to 23 months

• Percentage of Participants With Disease Control (DC)

  Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.

  Baseline till progression or death, whichever came first, assessed up to 23 months

Secondary Outcomes (3)

• 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

Study Arms (2)

BIBW 2992

EXPERIMENTAL

Patients receive BIBW 2992 tablets once daily

Drug: BIBW 2992

Cetuximab

ACTIVE COMPARATOR

Patients receive cetuximab intravenously once a week, every week

Drug: Cetuximab

Interventions

BIBW 2992 DRUG

Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management

BIBW 2992

Cetuximab DRUG

Patients receive cetuximab intravenously, once a week, every week

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

1200.74.44001 Boehringer Ingelheim Investigational Site

Bournemouth, United Kingdom

Location

1200.74.44005 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

Location

1200.74.44006 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

1200.74.44003 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1200.74.44009 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1200.74.44012 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1200.74.44007 Boehringer Ingelheim Investigational Site

Northwood, United Kingdom

Location

1200.74.44013 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1200.74.44011 Boehringer Ingelheim Investigational Site

Poole, United Kingdom

Location

1200.74.44010 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

1200.74.44008 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

1200.74.44004 Boehringer Ingelheim Investigational Site

Sutton, Surrey, United Kingdom

Location

1200.74.44002 Boehringer Ingelheim Investigational Site

Truro, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Afatinib; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: June 26, 2014
• Results First Posted: November 21, 2013

Record last verified: 2014-05

Locations

GB (13)