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Completed

NCT Number: NCT01152437

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1200.74.44001 Boehringer Ingelheim Investigational Site, Bournemouth, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIBW 2992

Drug

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

Cetuximab

Drug

Patients receive cetuximab intravenously, once a week, every week

Primary outcomes

  1. Percentage of Participants With Objective Response

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

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

  2. Percentage of Participants With Disease Control (DC)

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

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

Secondary outcomes

  1. Progression Free Survival (PFS)

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

    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.

  2. Overall Survival (OS) Time

    Time frame: Baseline till death, assessed up to 23 months

    OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.

  3. Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)

    Time frame: day 8

    Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Jun 29, 2010
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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