NCT00594984

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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2008

Longer than P75 for phase_1

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

4.6 years

First QC Date

January 7, 2008

Last Update Submit

October 12, 2015

Conditions

Metastatic Colorectal Cancer (MCRC)

Outcome Measures

Primary Outcomes (2)

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

    PK C1D1-C2-D3, biomarker throughout the study

  • Safety and tolerability of interventions will be collected

    throughout the study on Part II

Secondary Outcomes (1)

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

    throughout the study on Part II

Study Arms (2)

Arm 1 - Phase 1

ACTIVE COMPARATOR

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

Drug: CetuximabDrug: IrinotecanDrug: BrivanibDrug: Brivanib Placebo

Arm 2 - Phase 2

PLACEBO COMPARATOR

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

Drug: CetuximabDrug: IrinotecanDrug: BrivanibDrug: Brivanib Placebo

Interventions

CetuximabDRUG

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

Also known as: Erbitux, BMS-564717
Arm 1 - Phase 1Arm 2 - Phase 2
IrinotecanDRUG

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

Arm 1 - Phase 1Arm 2 - Phase 2
BrivanibDRUG

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

Arm 1 - Phase 1
Brivanib PlaceboDRUG

Oral, tablet, QD, until progression

Arm 1 - Phase 1Arm 2 - Phase 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven MCRC
  • Prior irinotecan allowed
  • Prior Erbitux allowed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Usc/Norris Comprehensive Cancer Center Hospital

Los Angeles, California, 90033, United States

Location

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Local Institution

Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Local Institution

Odense C, 5000, Denmark

Location

Local Institution

Meldola Fc, 47014, Italy

Location

Local Institution

Milan, 20141, Italy

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Madrid, 28050, Spain

Location

Local Institution

Stockholm, 17176, Sweden

Location

Local Institution

Uppsala, 75185, Sweden

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CetuximabIrinotecanbrivanib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 4, 2015

Record last verified: 2015-10

Locations

DK(1)AR(1)IT(2)KR(1)US(4)ES(1)SE(2)