Colorectal CancerPhase 1/2NCT00908024
Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing BMS-754807 and cetuximab (Erbitux®) in people with Colorectal Cancer and Head and Neck Cancer, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial summary
The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis
- What is being tested?
- BMS-754807 and cetuximab (Erbitux®)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2009to 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
- ECOG status 0 - 1
- Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
- Dose expansion: CRC (KRAS-WT) and head \& neck cancer subjects only
- must be able to provide 2 fresh tumor biopsy samples
- must have failed one prior cetuximab-containing treatment
Who cannot join
- Symptomatic brain metastasis
- Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
- Any condition requiring chronic use of steroids
- Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
- History of glucose intolerance
- History of cetuximab infusion reactions
- Women of child-bearing potential unwilling or unable to use acceptable contraception methods
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
University Of Wisconsin
Madison, Wisconsin, 53705
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Canada2 sites
Local Institution
Toronto, Ontario, M5G 2M9
Local Institution
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective
- Conditions
- Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis
- Being tested
- BMS-754807, cetuximab (Erbitux®)
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-754807Drug
Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision
cetuximab (Erbitux®)Drug
Also called Eributux®
IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision
| Study group | Role | What they receive |
|---|---|---|
| BMS-754807 + cetuximab | Experimental | Combination Receives: Drug: BMS-754807; Drug: cetuximab (Erbitux®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration
Measured: During and at the end of the first 33 days after the first dose of BMS-754807 is given
Secondary outcomes (4)
To assess anti-tumor activity as measured by objective responses
Measured: every 8 weeks
To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen
Measured: Ongoing
To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis
Measured: Ongoing
Dose Expansion only: To identify biomarkers that are predictive of a response to BMS-754807/cetuximab combination therapy in advanced or metastatic CRC and SCCHN subjects with cetuximab resistance
Measured: tumor biopsies before treatment and on day 33 +/- 3 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startOct 2009
- 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 Colorectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT00908024
- Sponsor's protocol ID
- CA191-006
- Other IDs
- EUDRACT: 2009-013766-78
- Status last verified
- Jun 2013
- First submitted
- 22 May 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00908024
- Acronym / sponsor ID
- CA191-006
- Conditions
- Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 May 2009 (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.
The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-754807 + cetuximab | Experimental | Drug: BMS-754807, Drug: cetuximab (Erbitux®)Combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG status 0 - 1
- Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
- Dose expansion: CRC (KRAS-WT) and head \& neck cancer subjects only
Key exclusion criteria (7 listed)
- Symptomatic brain metastasis
- Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
- Any condition requiring chronic use of steroids
- Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
- History of glucose intolerance
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 |
|---|---|---|
| BMS-754807Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision | Drug | BMS-754807 + cetuximab |
| cetuximab (Erbitux®)Also: Eributux®IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision | Drug | BMS-754807 + cetuximab |
Primary outcome
Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration
Time frame: During and at the end of the first 33 days after the first dose of BMS-754807 is given
4 secondary outcomes
To assess anti-tumor activity as measured by objective responses
Time frame: every 8 weeks
To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen
Time frame: Ongoing
To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis
Time frame: Ongoing
Dose Expansion only: To identify biomarkers that are predictive of a response to BMS-754807/cetuximab combination therapy in advanced or metastatic CRC and SCCHN subjects with cetuximab resistance
Time frame: tumor biopsies before treatment and on day 33 +/- 3 of treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-754807 and cetuximab (Erbitux®) in people with Colorectal Cancer and Head and Neck Cancer, run by Bristol-Myers Squibb at 5 sites in 2 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 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 was stopped early. Results are not available in the source record.
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?
Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration (time frame: During and at the end of the first 33 days after the first dose of BMS-754807 is given). 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 18 Jun 2013.