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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908024
Recruitment Status : Terminated
First Posted : May 25, 2009
Last Update Posted : June 18, 2013
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Head and Neck Cancer Neoplasm Metastasis Drug: BMS-754807 Drug: cetuximab (Erbitux®) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
Study Start Date : October 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: BMS-754807 + cetuximab
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
Other Name: Eributux®

Primary Outcome Measures :
  1. 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 [ Time Frame: During and at the end of the first 33 days after the first dose of BMS-754807 is given ]

Secondary Outcome Measures :
  1. To assess anti-tumor activity as measured by objective responses [ Time Frame: every 8 weeks ]
  2. To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen [ Time Frame: Ongoing ]
  3. To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis [ Time Frame: Ongoing ]
  4. 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 [ Time Frame: tumor biopsies before treatment and on day 33 +/- 3 of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 methods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908024

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United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53705
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT00908024    
Other Study ID Numbers: CA191-006
EUDRACT: 2009-013766-78
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Immunological
Antineoplastic Agents