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

NCT00908024 | Terminated Phase 1

• 2 other identifiers: CA191-006EUDRACT: 2009-013766-78
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 5

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

Conditions

Colorectal Cancer; Head and Neck Cancer; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

BMS-754807 + cetuximab

EXPERIMENTAL

Combination

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

Interventions

BMS-754807 DRUG

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

BMS-754807 + cetuximab

cetuximab (Erbitux®) DRUG

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

Also known as: Eributux®

BMS-754807 + cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• must be able to provide 2 fresh tumor biopsy samples
• must have failed one prior cetuximab-containing treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Local Institution

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms; Neoplasm Metastasis

Interventions

BMS 754807; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (3); CA (2)