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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
Not Enrolling
Both
Colorectal Cancer

Thank you

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 CenterLos Angeles, California  90033-0800
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Karmanos Cancer InstituteDetroit, Michigan  48201
Georgetn Univ Lombardi Can CtrWashington, District of Columbia  20007
University Of Miami Miller School Of MedicineMiami, Florida  33010