A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
18 Years
N/A
Both
Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis
Trial Information
A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
- ECOG status 0 - 1
- Dose escalation: Subjects with locally advanced or metastatic solid tumors who are
eligible to receive cetuximab treatment and have archived tumor biopsy material
available. Colorectal cancer subjects must be confirmed KRAS wild type
- Dose expansion: CRC (KRAS-WT) and head & neck cancer subjects only
1. must be able to provide 2 fresh tumor biopsy samples
2. must have failed one prior cetuximab-containing treatment
Exclusion Criteria:
- Symptomatic brain metastasis
- Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents,
experimental or licensed
- Any condition requiring chronic use of steroids
- Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2
Diabetes Mellitus or prediabetic symptoms)
- History of glucose intolerance
- History of cetuximab infusion reactions
- Women of child-bearing potential unwilling or unable to use acceptable contraception
methods
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration
Outcome Time Frame:
During and at the end of the first 33 days after the first dose of BMS-754807 is given
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:
CA191-006
NCT ID:
NCT00908024
Start Date:
October 2009
Completion Date:
December 2012
Related Keywords:
- Colorectal Cancer
- Head and Neck Cancer
- Neoplasm Metastasis
- Neoplasms
- Colorectal Neoplasms
- Head and Neck Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Duke University Medical Center | Durham, North Carolina 27710 |
| Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
