Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

Condition(s) targeted: Colorectal Cancer; Head and Neck Cancer; Neoplasm Metastasis

Intervention: BMS-754807 (Drug); cetuximab (Erbitux®) (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

To assess anti-tumor activity as measured by objective responses

To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen

To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis

Dose Expansion only: To identify biomarkers that are predictive of a response to BMS-754807/cetuximab combination therapy in advanced or metastatic CRC and SCCHN subjects with cetuximab resistance

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Vancouver, British Columbia V5Z 4E6, Canada; Recruiting
Site 003

Local Institution, Rochester, Minnesota 55905, United States; Not yet recruiting
Site 005

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States; Recruiting
Yungpo-Bernard Su, Site 006

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Hope Uronis, Site 004

Local Institution, Toronto, Ontario M5G 2M9, Canada; Recruiting
Site 002

Local Institution, Pittsburgh, Pennsylvania 15228, United States; Not yet recruiting
Site 008

Local Institution, Houston, Texas 77024, United States; Not yet recruiting
Site 007

University Of Wisconsin, Madison, Wisconsin 53705, United States; Recruiting
Anne Traynor, Site 001

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: October 2009
Last updated: November 29, 2011