Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | November 2007 |
| End Date: | July 2014 |
| 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 |
A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
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
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
We found this trial at
6
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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