A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

NCT ID: NCT00351325

Last Updated: 2009-09-04

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Detailed Description

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Conditions

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Advanced Solid Malignancies

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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dose escalation

Group Type EXPERIMENTAL

BMS-663513

Intervention Type DRUG

mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

Interventions

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BMS-663513

mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good activity level
* Life expectancy of ≥ 6 months
* Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria

* Major surgery within 4 weeks
* Any concurrent cancer
* History of autoimmune diseases
* Symptomatic bowel obstruction
* Continued use of steroids
* Symptomatic brain metastases
* Current nerve damage in fingers/toes
* Positive for HIV, hepatitis B/C
* White blood cells \< 3,000
* Hemoglobin \< 9
* Platelets \< 100,000
* ALT/AST and/or alkaline phosphatase \>= 2.5 x ULN
* Creatine \> 1.5
* Prior BMS-663513
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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University Of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Magee-Womens Hospital Of Upmc

Pittsburgh, Pennsylvania, United States

Site Status

University Of Virginia

Charlottesville, Virginia, United States

Site Status

University Of Washington

Seattle, Washington, United States

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CA186-004

Identifier Type: -

Identifier Source: org_study_id

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