Japanese Phase 1 Study of BMS-844203 (CT322)

NCT ID: NCT01146171

Last Updated: 2012-02-07

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-844203 (CT-322)

Group Type EXPERIMENTAL

BMS-844203 (CT-322)

Intervention Type DRUG

Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent

Interventions

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BMS-844203 (CT-322)

Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria

* Subject has uncontrolled diabetes or hypertension
* Clinical significant bleeding diathesis or coagulopathy
* Thrombotic or embolic cerebrovascular accident
Minimum Eligible Age

20 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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Local Institution

Osaka-Sayama-Shi, Osaka, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA196-007

Identifier Type: -

Identifier Source: org_study_id

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