Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00908024
Recruitment Status : Terminated
First Posted : May 25, 2009
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date June 18, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • To assess anti-tumor activity as measured by objective responses [ Time Frame: every 8 weeks ]
  • To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen [ Time Frame: Ongoing ]
  • To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis [ Time Frame: Ongoing ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Head and Neck Cancer
  • Neoplasm Metastasis
Intervention  ICMJE
  • 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®
Study Arms  ICMJE Experimental: BMS-754807 + cetuximab
Combination
Interventions:
  • Drug: BMS-754807
  • Drug: cetuximab (Erbitux®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
75
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908024
Other Study ID Numbers  ICMJE CA191-006
EUDRACT: 2009-013766-78
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP