Status:
TERMINATED
Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Colorectal Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- must be able to provide 2 fresh tumor biopsy samples
- must have failed one prior cetuximab-containing treatment
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00908024
Start Date
October 1 2009
End Date
December 1 2012
Last Update
June 18 2013
Active Locations (5)
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1
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
University Of Wisconsin
Madison, Wisconsin, United States, 53705
4
Local Institution
Vancouver, British Columbia, Canada, V5Z 4E6