CancerPhase 1NCT00479583
Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
A Phase 1 study testing BMS-690514 / FOLFIRI and BMS-690514 / FOLFOX in people with Cancer, run by Bristol-Myers Squibb at 4 sites in 2 countries.
Trial summary
The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- BMS-690514 / FOLFIRI and BMS-690514 / FOLFOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2007to Apr 2010
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for FOLFIRI or FOLFOX therapy
- ECOG performance status score 0-1
- At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
- At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
- No maximum age for Study Arm A (FOLFOX)
- 18-65 years of age for Study Arm B (FOLFIRI)
Who cannot join
- Treatment with other TKIs within the past 4 weeks
- Active inflammatory bowel disease
- Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
- History of thromboembolism
- Severe unmanageable diarrhea
- Uncontrolled or significant cardiovascular disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
France2 sites
Local Institution
Saint-Herblain, 44805
Local Institution
Villejuif, 94805
About this study
Official title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
- Conditions
- Cancer
- Being tested
- BMS-690514 / FOLFIRI, BMS-690514 / FOLFOX
- Keywords
- Cancer (solid tumors)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-690514 / FOLFIRIDrug
Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
BMS-690514 / FOLFOXDrug
Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: BMS-690514 / FOLFIRI |
| B | Active comparator | Not described Receives: Drug: BMS-690514 / FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Measured: throughout the study
dose-limiting toxicity (DLT)
Measured: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Measured: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Secondary outcomes (2)
Describe anti-tumor of combination therapy
Measured: Every 8 weeks throughout the study
Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples
Measured: throughtout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479583
- Sponsor's protocol ID
- CA187-005
- Status last verified
- Mar 2011
- First submitted
- 24 May 2007
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00479583
- Acronym / sponsor ID
- CA187-005
- Conditions
- Cancer
- Keywords
- Cancer (solid tumors)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 May 2007 (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 this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: BMS-690514 / FOLFIRI |
| B | Active comparator | Drug: BMS-690514 / FOLFOX |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients eligible for FOLFIRI or FOLFOX therapy
- ECOG performance status score 0-1
- At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
- At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
- No maximum age for Study Arm A (FOLFOX)
Key exclusion criteria (6 listed)
- Treatment with other TKIs within the past 4 weeks
- Active inflammatory bowel disease
- Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
- History of thromboembolism
- Severe unmanageable diarrhea
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-690514 / FOLFIRITablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos | Drug | A |
| BMS-690514 / FOLFOXTablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos | Drug | B |
Primary outcome
Safety assessment
Time frame: throughout the study
dose-limiting toxicity (DLT)
Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
2 secondary outcomes
Describe anti-tumor of combination therapy
Time frame: Every 8 weeks throughout the study
Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples
Time frame: throughtout the 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 30 Nov 2011.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-690514 / FOLFIRI and BMS-690514 / FOLFOX in people with Cancer, run by Bristol-Myers Squibb at 4 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 6 inclusion and 6 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 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France. 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 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.
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?
Safety assessment (time frame: throughout the study). The study lists 3 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 30 Nov 2011.