NCT00908024

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Colorectal Cancer
• Head and Neck Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	BMS-754807	Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision
DRUG	cetuximab (Erbitux®)	IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-05-25
• Last updated: 2013-06-18

Locations

5 sites across 2 countries: United States, Canada