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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Neoplasm Metastasis; Head and Neck Cancer; Colorectal Cancer

Treatments: Drug: BMS-754807; Drug: cetuximab (Erbitux®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908024

EUDRACT: 2009-013766-78

CA191-006

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

BMS-754807 + cetuximab

Experimental group

Description:

Combination

Treatment:

Drug: BMS-754807

Drug: cetuximab (Erbitux®)