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

Primary Purpose

Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-754807

cetuximab (Erbitux®)

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nebraska Methodist Hospital
Duke University Medical Center
University Of Wisconsin
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-754807 + cetuximab

Arm Description

Combination

Outcomes

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

Secondary Outcome Measures

To assess anti-tumor activity as measured by objective responses

To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen

To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis

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

Full Information

NCT ID

NCT00908024

First Posted

May 22, 2009

Last Updated

June 17, 2013

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00908024

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Terminated

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-754807 + cetuximab

Arm Type

Experimental

Arm Description

Combination

Intervention Type

Drug

Intervention Name(s)

BMS-754807

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cetuximab (Erbitux®)

Other Intervention Name(s)

Eributux®

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

To assess anti-tumor activity as measured by objective responses

Time Frame

every 8 weeks

Title

To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen

Time Frame

Ongoing

Title

To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis

Time Frame

Ongoing

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 must be able to provide 2 fresh tumor biopsy samples 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Nebraska Methodist Hospital

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University Of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

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

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