Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Brivanib
- Conditions
- Tumors
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 68
- Locations
- 4
- Primary Endpoint
- Safety assessment
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
Investigators
Eligibility Criteria
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)
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: Brivanib
2
Intervention: Brivanib
3
Intervention: Brivanib
4
Intervention: Brivanib
5
Intervention: Brivanib
6
Intervention: Brivanab
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy based on duration of response and time to progression based on assessment(measured every 8 weeks throughout the study)