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Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

NCT ID: NCT00516451

Last Updated: 2008-10-13

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.

Detailed Description

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Conditions

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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

BMS-690514

Intervention Type DRUG

Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more

Interventions

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BMS-690514

Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.
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

Chuo-Ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Nokihara H, Yamamoto N, Yamada Y, Yamada K, Hirata T, Goto Y, Tanioka M, Ikeda Y, Tamura T. A phase I study of BMS-690514 in Japanese patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2012 Oct;70(4):559-65. doi: 10.1007/s00280-012-1932-9. Epub 2012 Aug 10.

Reference Type DERIVED
PMID: 22878519 (View on PubMed)

Other Identifiers

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CA187-006

Identifier Type: -

Identifier Source: org_study_id