Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

NCT ID: NCT00038428

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.

Detailed Description

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Conditions

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Ovarian 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 ovarian cancer
* Recurrent or persistent disease following primary therapy
* Measurable disease
* Prior treatment with at least one but no more than three prior chemotherapy regimens
* Resistant or refractory to platinum-based chemotherapy
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal and bone marrow function

Exclusion Criteria

* Pregnant or currently breast feeding
* Treatment with chemotherapy or immunotherapy within four weeks
* Prior radiation to the whole pelvis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

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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USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TLK286.2003

Identifier Type: -

Identifier Source: org_study_id

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