Metastatic Colorectal Cancer (MCRC)Phase 1/2NCT00594984
Phase I/II Combination With Irinotecan- Erbitux
A Phase 1/2 study testing Cetuximab, Irinotecan and Brivanib in people with Metastatic Colorectal Cancer (MCRC), run by Bristol-Myers Squibb at 12 sites in 7 countries.
Trial summary
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC) Part 2: To compare median duration of progression free survival (PFS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (MCRC)
- What is being tested?
- Cetuximab, Irinotecan and Brivanib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 12 sitesin 7 countries
- Study dates
- May 2008to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Biopsy proven MCRC
- Prior irinotecan allowed
- Prior Erbitux allowed
Who cannot join
- No prior brivanib
- No prior combination of irinotecan with Erbitux
- No secondary malignancies
- No anti-coagulation therapy
- No prior history of blood clots requiring anti-coagulation
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
United States4 sites
Usc/Norris Comprehensive Cancer Center Hospital
Los Angeles, California, 90033
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Washington University
St Louis, Missouri, 63110
Sweden2 sites
Local Institution
Stockholm, 17176
Local Institution
Uppsala, 75185
About this study
Official title: A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
Part 2: To compare median duration of progression free survival (PFS)
- Conditions
- Metastatic Colorectal Cancer (MCRC)
- Being tested
- Cetuximab, Irinotecan, Brivanib, Brivanib Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux, BMS-564717
IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
IrinotecanDrug
IV solution, IV, Q3W, 350 mg/m2, until progression
BrivanibDrug
Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
BrivanibDrug
Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
Brivanib PlaceboDrug
Oral, tablet, QD, until progression
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Phase 1 | Active comparator | Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo Receives: Drug: Cetuximab; Drug: Irinotecan; Drug: Brivanib; Drug: Brivanib Placebo |
| Arm 2 - Phase 2 | Placebo comparator | Cetuximab + Irinotecan + Brivanib
OR
Cetuximab + Irinotecan + Brivanib Placebo Receives: Drug: Cetuximab; Drug: Irinotecan; Drug: Brivanib; Drug: Brivanib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Measured: PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
Measured: throughout the study on Part II
Secondary outcomes (1)
Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects
Measured: throughout the study on Part II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (MCRC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594984
- Sponsor's protocol ID
- CA182-025
- Other IDs
- 2007-005097-31
- Status last verified
- Oct 2015
- First submitted
- 7 Jan 2008
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00594984
- Acronym / sponsor ID
- CA182-025
- Conditions
- Metastatic Colorectal Cancer (MCRC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
Part 2: To compare median duration of progression free survival (PFS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Phase 1 | Active comparator | Drug: Cetuximab, Drug: Irinotecan, Drug: Brivanib, Drug: Brivanib PlaceboCetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
| Arm 2 - Phase 2 | Placebo comparator | Drug: Cetuximab, Drug: Irinotecan, Drug: Brivanib, Drug: Brivanib PlaceboCetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy proven MCRC
- Prior irinotecan allowed
- Prior Erbitux allowed
Key exclusion criteria (5 listed)
- No prior brivanib
- No prior combination of irinotecan with Erbitux
- No secondary malignancies
- No anti-coagulation therapy
- No prior history of blood clots requiring anti-coagulation
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 |
|---|---|---|
| CetuximabAlso: Erbitux, BMS-564717IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression | Drug | Arm 1 - Phase 1, Arm 2 - Phase 2 |
| IrinotecanIV solution, IV, Q3W, 350 mg/m2, until progression | Drug | Arm 1 - Phase 1, Arm 2 - Phase 2 |
| BrivanibOral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression | Drug | Arm 1 - Phase 1 |
| BrivanibOral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression | Drug | Arm 2 - Phase 2 |
| Brivanib PlaceboOral, tablet, QD, until progression | Drug | Arm 1 - Phase 1, Arm 2 - Phase 2 |
Primary outcome
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
Time frame: PK C1D1-C2-D3, biomarker throughout the study
Safety and tolerability of interventions will be collected
Time frame: throughout the study on Part II
1 secondary outcome
Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects
Time frame: throughout the study on Part II
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cetuximab, Irinotecan and Brivanib in people with Metastatic Colorectal Cancer (MCRC), run by Bristol-Myers Squibb at 12 sites in 7 countries.
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 3 inclusion and 5 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 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, Sweden, Argentina, Denmark and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial (time frame: PK C1D1-C2-D3, biomarker throughout the study). 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?
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 4 Nov 2015.