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A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis

Thank you

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 Please visit 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

Type of Study:


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:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




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



Duke University Medical CenterDurham, North Carolina  27710
Nebraska Methodist HospitalOmaha, Nebraska  68114
University of WisconsinMadison,, Wisconsin  53792-5666