Neoplasm Metastasis, Tumors
Conditions
Keywords
Advanced metastatic or solid tumors
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.
Interventions
DRUGBrivanib
Tablets, Oral, 180 mg, once daily, until disease progression
DRUGBrivanab
Tablets, Oral, 1000 mg, once daily, until disease progression
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment | throughout the study |
| dose-limiting toxicity (DLT) | 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) | 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
| Measure | Time frame |
|---|---|
| Efficacy based on duration of response and time to progression based on assessment | measured every 8 weeks throughout the study |
Countries
Canada, Italy, United Kingdom, United States
Outcome results
None listed