Colorectal NeoplasmsPhase 2NCT01152437

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

A Phase 2 study testing BIBW 2992 and Cetuximab in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 13 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Neoplasms
What is being tested?: BIBW 2992 and Cetuximab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 13 sitesUnited Kingdom
Study dates: Jun 2010to Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United Kingdom13 sites

1200.74.44001 Boehringer Ingelheim Investigational Site
Bournemouth
1200.74.44005 Boehringer Ingelheim Investigational Site
Bristol
1200.74.44006 Boehringer Ingelheim Investigational Site
Cambridge
1200.74.44003 Boehringer Ingelheim Investigational Site
Glasgow
1200.74.44009 Boehringer Ingelheim Investigational Site
London
1200.74.44012 Boehringer Ingelheim Investigational Site
Manchester
1200.74.44007 Boehringer Ingelheim Investigational Site
Northwood
1200.74.44013 Boehringer Ingelheim Investigational Site
Nottingham
1200.74.44011 Boehringer Ingelheim Investigational Site
Poole
1200.74.44010 Boehringer Ingelheim Investigational Site
Sheffield
1200.74.44008 Boehringer Ingelheim Investigational Site
Southampton
1200.74.44004 Boehringer Ingelheim Investigational Site
Sutton, Surrey
1200.74.44002 Boehringer Ingelheim Investigational Site
Truro

Other trials in United Kingdom

About this study

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

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
Being tested: BIBW 2992, Cetuximab
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIBW 2992Drug
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
CetuximabDrug
Patients receive cetuximab intravenously, once a week, every week

Study groups in NCT01152437
Study group	Role	What they receive
BIBW 2992	Experimental	Patients receive BIBW 2992 tablets once daily Receives: Drug: BIBW 2992
Cetuximab	Active comparator	Patients receive cetuximab intravenously once a week, every week Receives: Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Progression Free Survival (PFS)
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.
Measured: Baseline till progression or death, whichever came first, assessed up to 23 months
Overall Survival (OS) Time
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.
Measured: Baseline till death, assessed up to 23 months
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
Measured: day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Mar 2012

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152437
Sponsor's protocol ID: 1200.74
Other IDs: 2009-011996-59, 2009
Status last verified: May 2014
First submitted: 28 Jun 2010
Last updated: 26 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01152437
Acronym / sponsor ID: 1200.74
Conditions: Colorectal Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Mar 2012 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 21 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BIBW 2992	Experimental	Drug: BIBW 2992Patients receive BIBW 2992 tablets once daily
Cetuximab	Active comparator	Drug: CetuximabPatients receive cetuximab intravenously once a week, every week

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIBW 2992Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management	Drug	BIBW 2992
CetuximabPatients receive cetuximab intravenously, once a week, every week	Drug	Cetuximab

Primary outcome

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.
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.

3 secondary outcomes

Progression Free Survival (PFS)
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Overall Survival (OS) Time
Time frame: Baseline till death, assessed up to 23 months
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Time frame: day 8

Results and safety

Results posted to the registry on 21 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib (Wild-type)	36	0
Cetuximab (Wild-type)	15	0
Afatinib (Mutated)	43	0

Primary outcome: Percentage of Participants With Objective Response

Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months. Number. Unit: Percentage of Participants

Measure	Afatinib (Wild-type) n = 36	Cetuximab (Wild-type) n = 15
Value	3	20

Afatinib (Wild-type) vs Cetuximab (Wild-type): Odds Ratio (OR): 0.122 (90% CI 0.018 to 0.844), p = 0.0735, Regression, Logistic

Population analysed: Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours.

Primary outcome: Percentage of Participants With Disease Control (DC)

Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months. Number (90% Confidence Interval). Unit: Percentage of Participants

Measure	Afatinib (Mutated) n = 41
Value	12 (4.9 to 23.9)

Afatinib (Mutated): Percentage of participants: 12 (90% CI 4.9 to 23.9), p = 0.6394, Exact binomial test

Population analysed: Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration of trial medication until 28 days after last administration of trial medication. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib (Wild-type)	15 of 36 (41.7%)	35 of 36 (97.2%)	Not reported
Cetuximab (Wild-type)	5 of 14 (35.7%)	14 of 14 (100%)	Not reported
Afatinib (Mutated)	18 of 41 (43.9%)	40 of 41 (97.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBW 2992 and Cetuximab in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 13 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Objective Response (time frame: Baseline till progression or death, whichever came first, assessed up to 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.