Phase 2 Study of TLK286 in Metastatic Breast Cancer

NCT ID: NCT00035841

Last Updated: 2011-07-25

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-07-31

Brief Summary

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The purpose of this study is to determine the effectiveness of TLK286 in treatment of metastatic breast cancer.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TLK286

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic diagnosis of breast cancer
* Metastatic disease
* Measurable or evaluable disease
* No prior chemotherapy regimens
* Age at least 18 years
* Adequate liver and kidney function
* Adequate bone marrow function

Exclusion Criteria

* Pregnant or lactating women
* Unstable medical conditions
* Chemotherapy within 14 days of TLK286
* Radiation therapy within 14 days of TLK286
* Hormonal therapy within 14 days of TLK286
* Immunotherapy within 14 days of TLK286
* CNS metastasis unless controlled by treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Telik, Inc.

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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TLK286.2008

Identifier Type: -

Identifier Source: org_study_id

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