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MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

NCT ID: NCT00207103

Last Updated: 2008-11-04

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-09-30

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 patients with advanced or metastatic solid tumors.

Detailed Description

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Conditions

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Tumors Neoplasm Metastasis

Keywords

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Advanced metastatic or solid tumors

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

Intervention Type DRUG

Tablets, Oral, 180 mg, once daily, until disease progression

2

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 320 mg, once daily, until disease progression

3

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 600 mg, once daily, until disease progression

4

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 800 mg, once daily, until disease progression

5

Group Type EXPERIMENTAL

Brivanib

Intervention Type DRUG

Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression

6

Group Type EXPERIMENTAL

Brivanab

Intervention Type DRUG

Tablets, Oral, 1000 mg, once daily, until disease progression

Interventions

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Brivanib

Tablets, Oral, 180 mg, once daily, until disease progression

Intervention Type DRUG

Brivanib

Tablets, Oral, 320 mg, once daily, until disease progression

Intervention Type DRUG

Brivanib

Tablets, Oral, 600 mg, once daily, until disease progression

Intervention Type DRUG

Brivanib

Tablets, Oral, 800 mg, once daily, until disease progression

Intervention Type DRUG

Brivanib

Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression

Intervention Type DRUG

Brivanab

Tablets, Oral, 1000 mg, once daily, until disease progression

Intervention Type DRUG

Other Intervention Names

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BMS-582664 BMS-582664 BMS-582664 BMS-582664 BMS-582664 BMS-582664

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
* No tumor spread to the brain
* Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
* Available tumor tissue sample from prior surgery
* 4-6 weeks since prior therapy and recovered from prior therapy
* Men and women, ages 18 and above
* Women must not be pregnant or breastfeeding
* Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
* Measurable disease on scans (at least one)
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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Premiere Oncology

Santa Monica, California, United States

Site Status

Indiana University Med Center

Indianapolis, Indiana, United States

Site Status

University Of Wisconsin Comprehensive Center

Madison, Wisconsin, United States

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution

Milan, , Italy

Site Status

Local Institution

Middlesex, Greater London, United Kingdom

Site Status

Local Institution

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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Australia United States Canada Italy United Kingdom

Other Identifiers

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CA182-002

Identifier Type: -

Identifier Source: org_study_id