Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

NCT ID: NCT01018966

Last Updated: 2017-01-30

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-04-30

Brief Summary

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The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

Detailed Description

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Conditions

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Solid Tumors

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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Ixabepilone

Group Type EXPERIMENTAL

Ixabepilone

Intervention Type DRUG

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)

Interventions

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Ixabepilone

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)

Intervention Type DRUG

Other Intervention Names

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Ixempra BMS-247550

Eligibility Criteria

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Inclusion Criteria

* 20 years or older
* Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion Criteria

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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R-Pharm

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

Related Links

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Other Identifiers

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CA163-029

Identifier Type: -

Identifier Source: org_study_id

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