TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

NCT ID: NCT00051948

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

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-01-31

Brief Summary

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This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.

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

* Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
* Recurrent ovarian cancer or persistent disease following primary treatment
* At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
* At least 18 years of age

Exclusion Criteria

* Pregnant or lactating women
* History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years
* Known leptomeningeal metastases or carcinomatous meningitis
* Having received whole pelvis radiation therapy
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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Santa Monica Hematology/Oncology Consultants

Santa Monica, California, United States

Site Status

Midwest Cancer Research Group, Inc.

Skokie, Illinois, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, 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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TLK286.2018

Identifier Type: -

Identifier Source: org_study_id

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