Colorectal CancerPhase 1/2NCT01086267
Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
A Phase 1/2 study testing BMS-908662 and Cetuximab in people with Colorectal Cancer, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- BMS-908662 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
- 17 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2010to Aug 2011
- 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
- Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
- Histologic or cytologic confirmation of the diagnosis.
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Adequate organ \& marrow function.
Who cannot join
- Uncontrolled or significant cardiovascular disease.
- Phase 2: Prior therapy with a RAF inhibitor.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Oncology Research Associates D/B/A
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab
Read the detailed description
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
- Conditions
- Colorectal Cancer
- Being tested
- BMS-908662, 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.
BMS-908662Drug
Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
BMS-908662Drug
Capsules, Oral, (TBD) mg, Q 12 h, Continuously
CetuximabDrug
Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
| Study group | Role | What they receive |
|---|---|---|
| BMS-908662 (A1) | Experimental | Phase 1 Receives: Drug: BMS-908662 |
| Cetuximab (A1) | Experimental | Phase 1 Receives: Drug: Cetuximab |
| BMS-908662 (B1) | Experimental | Phase 2 Receives: Drug: BMS-908662 |
| BMS-908662 + Cetuximab (B2) | Experimental | Phase 2 Receives: Drug: BMS-908662; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Measured: Assessments every 1-2 weeks while receiving study drug
Secondary outcomes (7)
Efficacy as determined by estimates of objective response rates and response duration
Measured: Efficacy measured at least every 8 weeks while receiving study drug
Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity
Measured: PD assessed during the first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].
Measured: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].
Measured: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].
Measured: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].
Measured: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].
Measured: PK measured during first 4 weeks on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionAug 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01086267
- Sponsor's protocol ID
- CA206-001
- Other IDs
- 2010-018944-15
- Status last verified
- Jun 2016
- First submitted
- 11 Mar 2010
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01086267
- Acronym / sponsor ID
- CA206-001
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Mar 2010 (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 purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab
Detailed description
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-908662 (A1) | Experimental | Drug: BMS-908662Phase 1 |
| Cetuximab (A1) | Experimental | Drug: CetuximabPhase 1 |
| BMS-908662 (B1) | Experimental | Drug: BMS-908662Phase 2 |
| BMS-908662 + Cetuximab (B2) | Experimental | Drug: BMS-908662, Drug: CetuximabPhase 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
- Histologic or cytologic confirmation of the diagnosis.
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Adequate organ \& marrow function.
Key exclusion criteria (2 listed)
- Uncontrolled or significant cardiovascular disease.
- Phase 2: Prior therapy with a RAF inhibitor.
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-908662Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously | Drug | BMS-908662 (A1) |
| BMS-908662Capsules, Oral, (TBD) mg, Q 12 h, Continuously | Drug | BMS-908662 (B1), BMS-908662 + Cetuximab (B2) |
| CetuximabVial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously | Drug | BMS-908662 + Cetuximab (B2), Cetuximab (A1) |
Primary outcome
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Time frame: Assessments every 1-2 weeks while receiving study drug
7 secondary outcomes
Efficacy as determined by estimates of objective response rates and response duration
Time frame: Efficacy measured at least every 8 weeks while receiving study drug
Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity
Time frame: PD assessed during the first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].
Time frame: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].
Time frame: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].
Time frame: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].
Time frame: PK measured during first 4 weeks on study
Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].
Time frame: PK measured during first 4 weeks on study
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 27 Jun 2016.
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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
3 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-908662 and Cetuximab in people with Colorectal Cancer, run by Bristol-Myers Squibb at 3 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 4 inclusion and 2 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3 (time frame: Assessments every 1-2 weeks while receiving study drug). 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 27 Jun 2016.