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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00479583 |
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Date of registration:
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24/05/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX
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Scientific title:
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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 |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00479583 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: BMS-690514 / FOLFOX
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Drug: BMS-690514 / FOLFIRI
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Primary Outcome(s)
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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]
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Safety assessment
[Time Frame: throughout the study]
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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]
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Secondary Outcome(s)
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Describe anti-tumor of combination therapy
[Time Frame: Every 8 weeks throughout the study]
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Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples
[Time Frame: throughtout the study]
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Secondary ID(s)
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CA187-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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