BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

NCT ID: NCT00207051

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Brivanib + Cetuximab

Intervention Type DRUG

Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks

Interventions

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Brivanib + Cetuximab

Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks

Intervention Type DRUG

Other Intervention Names

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Erbitux BMS-564717

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy
* Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
* Available tumor tissue sample from prior surgery
* Measurable disease on scans
* 4-6 weeks since prior therapy and recovered from the effects of prior therapy
* Men and women, ages 18 and above
* Women must not be pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Usc/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Georgetn Univ Lombardi Can Ctr

Washington D.C., District of Columbia, United States

Site Status

University Of Miami Miller School Of Medicine

Miami, Florida, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Local Institution

Hamilton, Ontario, Canada

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Local Institution

Amsterdam, , Netherlands

Site Status

Countries

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United States Canada Netherlands

References

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Jonker DJ, Rosen LS, Sawyer MB, de Braud F, Wilding G, Sweeney CJ, Jayson GC, McArthur GA, Rustin G, Goss G, Kantor J, Velasquez L, Syed S, Mokliatchouk O, Feltquate DM, Kollia G, Nuyten DSA, Galbraith S. A phase I study to determine the safety, pharmacokinetics and pharmacodynamics of a dual VEGFR and FGFR inhibitor, brivanib, in patients with advanced or metastatic solid tumors. Ann Oncol. 2011 Jun;22(6):1413-1419. doi: 10.1093/annonc/mdq599. Epub 2010 Dec 3.

Reference Type DERIVED
PMID: 21131369 (View on PubMed)

Related Links

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Other Identifiers

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CA182-003

Identifier Type: -

Identifier Source: org_study_id

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