Colorectal Cancer
Conditions
Keywords
Advanced Gastrointestinal Malignancies
Brief summary
This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.
Interventions
DRUGBrivanib + Cetuximab
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
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 advanced or metastatic (tumor has spread) gastrointestinal malignancy * Feeling well other than cancer diagnosis (ie lab work, no infection, etc) * Available tumor tissue sample from prior surgery * Measurable disease on scans * 4-6 weeks since prior therapy and recovered from the effects of prior therapy * Men and women, ages 18 and above * Women must not be pregnant or breastfeeding
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 maximu 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, Netherlands, United States
Outcome results
None listed