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Phase I/II Combination With Irinotecan- Erbitux

Primary Purpose

Metastatic Colorectal Cancer (MCRC)

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Cetuximab

Irinotecan

Brivanib

Brivanib Placebo

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer (MCRC)

Eligibility Criteria

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

Inclusion Criteria:

Biopsy proven MCRC
Prior irinotecan allowed
Prior Erbitux allowed

Exclusion Criteria:

No prior brivanib
No prior combination of irinotecan with Erbitux
No secondary malignancies
No anti-coagulation therapy
No prior history of blood clots requiring anti-coagulation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 - Phase 1

Arm 2 - Phase 2

Arm Description

Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Outcomes

Primary Outcome Measures

Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial

Safety and tolerability of interventions will be collected

Secondary Outcome Measures

Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects

Full Information

NCT ID

NCT00594984

First Posted

January 7, 2008

Last Updated

October 12, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00594984

Brief Title

Phase I/II Combination With Irinotecan- Erbitux

Official Title

A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2008 (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

Yes

5. Study Description

Brief Summary

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC) Part 2: To compare median duration of progression free survival (PFS)

6. Conditions and Keywords

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

Metastatic Colorectal Cancer (MCRC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 - Phase 1

Arm Type

Active Comparator

Arm Description

Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Arm Title

Arm 2 - Phase 2

Arm Type

Placebo Comparator

Arm Description

Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux, BMS-564717

Intervention Description

IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

IV solution, IV, Q3W, 350 mg/m2, until progression

Intervention Type

Drug

Intervention Name(s)

Brivanib

Intervention Description

Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression

Intervention Type

Drug

Intervention Name(s)

Brivanib

Intervention Description

Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression

Intervention Type

Drug

Intervention Name(s)

Brivanib Placebo

Intervention Description

Oral, tablet, QD, until progression

Primary Outcome Measure Information:

Title

Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial

Time Frame

PK C1D1-C2-D3, biomarker throughout the study

Title

Safety and tolerability of interventions will be collected

Time Frame

throughout the study on Part II

Secondary Outcome Measure Information:

Title

Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects

Time Frame

throughout the study on Part II

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proven MCRC Prior irinotecan allowed Prior Erbitux allowed Exclusion Criteria: No prior brivanib No prior combination of irinotecan with Erbitux No secondary malignancies No anti-coagulation therapy No prior history of blood clots requiring anti-coagulation

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

Usc/Norris Comprehensive Cancer Center Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Usc/Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Local Institution

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution

City

Meldola Fc

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Local Institution

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

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

Phase I/II Combination With Irinotecan- Erbitux

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Phase I/II Combination With Irinotecan- Erbitux

Metastatic Colorectal Cancer (MCRC)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial