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

Phase 1

Terminated

• Conditions: Colorectal Cancer; Head and Neck Cancer; Neoplasm Metastasis
• Interventions: Drug: BMS-754807; Drug: cetuximab (Erbitux®)

• Registration Number: NCT00908024
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Study Start: 2009-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-754807 + cetuximab	cetuximab (Erbitux®)	Combination
BMS-754807 + cetuximab	BMS-754807	Combination

Primary Outcome Measures

Name	Time	Method
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	During and at the end of the first 33 days after the first dose of BMS-754807 is given

Secondary Outcome Measures

Name	Time	Method
To assess anti-tumor activity as measured by objective responses	every 8 weeks
To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen	Ongoing
To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis	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	tumor biopsies before treatment and on day 33 +/- 3 of treatment

Trial Locations

Locations (4)

University Of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Local Institution; 🇨🇦 Toronto, Ontario, Canada

Nebraska Methodist Hospital; 🇺🇸 Omaha, Nebraska, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States