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

Colorectal Cancer Clinical Trial

Official title:

A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00908024
• Other study ID #: CA191-006
• Secondary ID: EUDRACT: 2009-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 22, 2009
• Last updated: June 17, 2013
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• BMS-754807
Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision
• 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

Locations

Country	Name	City	State
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
United States	Duke University Medical Center	Durham	North Carolina
United States	University Of Wisconsin	Madison	Wisconsin
United States	Nebraska Methodist Hospital	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess anti-tumor activity as measured by objective responses		every 8 weeks	No
Secondary	To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen		Ongoing	Yes
Secondary	To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis		Ongoing	Yes
Secondary	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	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form