Gastrointestinal NeoplasmsPhase 1NCT00300027
Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies
A Phase 1 study testing BMS-582664 in people with Gastrointestinal Neoplasms, run by Bristol-Myers Squibb at 6 sites in United States.
Trial summary
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- BMS-582664
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2006to Dec 2006
- 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
- Good performance status
- Advanced colorectal, pancreatic, esophageal or gastric cancer
- Tissue for analyses
- Adequate bone marrow, hepatic, renal function
- 4-6 weeks since prior therapy
- Adequate protection for women of child bearing potential (WOCBP)
Who cannot join
- Brain metastasis
- Thromboembolic disease
- Cardiovascular disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Local Institution
Durham, North Carolina
Local Institution
Iowa City, Iowa
Local Institution
Little Rock, Arkansas
Local Institution
Los Angeles, California
Local Institution
Temple, Texas
Local Institution
Washington D.C., District of Columbia
About this study
Official title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- BMS-582664
- Keywords
- Advanced Gastrointestinal Malignancies
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-582664Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Echocardiogram every 2 cycles (q 2 cycles)
Secondary outcomes (4)
Tumor response (q 2 cycles)
PK parameters (during 1st cycle)
PD markers (weekly)
Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300027
- Sponsor's protocol ID
- CA182-007
- Status last verified
- Sep 2007
- First submitted
- 6 Mar 2006
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. 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-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00300027
- Acronym / sponsor ID
- CA182-007
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Advanced Gastrointestinal Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 8 Mar 2006 (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 study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Good performance status
- Advanced colorectal, pancreatic, esophageal or gastric cancer
- Tissue for analyses
- Adequate bone marrow, hepatic, renal function
- 4-6 weeks since prior therapy
Key exclusion criteria (3 listed)
- Brain metastasis
- Thromboembolic disease
- Cardiovascular disease
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-582664 | Drug | – |
Primary outcome
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Echocardiogram every 2 cycles (q 2 cycles)
4 secondary outcomes
Tumor response (q 2 cycles)
PK parameters (during 1st cycle)
PD markers (weekly)
Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
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 2 Mar 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-582664 in people with Gastrointestinal Neoplasms, run by Bristol-Myers Squibb at 6 sites in United States.
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 3 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 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?
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw). 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 2 Mar 2010.