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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: |
NCT00207103 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
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Scientific title:
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Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00207103 |
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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: Parallel 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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Australia
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Canada
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Italy
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United Kingdom
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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:
- Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
- No tumor spread to the brain
- Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
- Available tumor tissue sample from prior surgery
- 4-6 weeks since prior therapy and recovered from prior therapy
- Men and women, ages 18 and above
- Women must not be pregnant or breastfeeding
- Diagnosis of advanced or metastatic (tumor that has spread) colorectal,
hepatocellular (liver) or renal (kidney) cancer
- Measurable disease on scans (at least one)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasm Metastasis
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Tumors
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Intervention(s)
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Drug: Brivanab
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Drug: Brivanib
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Primary Outcome(s)
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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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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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Secondary Outcome(s)
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Efficacy based on duration of response and time to progression based on assessment
[Time Frame: measured every 8 weeks throughout the study]
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Secondary ID(s)
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CA182-002
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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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