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 Gastrointestinal Malignancies Who Have Failed Prior Therapy
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
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 Gastrointestinal Malignancies Who Have Failed Prior Therapy
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety assessment
Outcome Time Frame:
throughout the study
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA182-003
NCT ID:
NCT00207051
Start Date:
January 2006
Completion Date:
December 2008
Related Keywords:
- Colorectal Cancer
- Advanced Gastrointestinal Malignancies
- Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Georgetn Univ Lombardi Can Ctr | Washington, District of Columbia 20007 |
| University Of Miami Miller School Of Medicine | Miami, Florida 33010 |
