Clinical trial NCT01152437: A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: Baseline till progression or death, whichever came first, assessed up to 23 months
measure: Percentage of Participants With Disease Control (DC)
timeFrame: Baseline till progression or death, whichever came first, assessed up to 23 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline till progression or death, whichever came first, assessed up to 23 months
measure: Overall Survival (OS) Time
timeFrame: Baseline till death, assessed up to 23 months
measure: Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
timeFrame: day 8
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: 1200.74.44001 Boehringer Ingelheim Investigational Site
city: Bristol
country: United Kingdom
facility: 1200.74.44005 Boehringer Ingelheim Investigational Site
city: Cambridge
country: United Kingdom
facility: 1200.74.44006 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1200.74.44003 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1200.74.44009 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1200.74.44012 Boehringer Ingelheim Investigational Site
city: Northwood
country: United Kingdom
facility: 1200.74.44007 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 1200.74.44013 Boehringer Ingelheim Investigational Site
city: Poole
country: United Kingdom
facility: 1200.74.44011 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 1200.74.44010 Boehringer Ingelheim Investigational Site
city: Southampton
country: United Kingdom
facility: 1200.74.44008 Boehringer Ingelheim Investigational Site
city: Sutton, Surrey
country: United Kingdom
facility: 1200.74.44004 Boehringer Ingelheim Investigational Site
city: Truro
country: United Kingdom
facility: 1200.74.44002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: