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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00908024
First received: May 22, 2009
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess anti-tumor activity as measured by objective responses [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-754807 + cetuximab
Combination
 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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908024

Locations
United States, Minnesota
Local Institution
Rochester, Minnesota, United States, 55905
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, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15228
United States, Texas
Local Institution
Houston, Texas, United States, 77024
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00908024     History of Changes
Other Study ID Numbers: CA191-006, EUDRACT: 2009-013766-78
Study First Received: May 22, 2009
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration
Canada: Ministry of Health & Long Term Care, Ontario

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013