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

July 21, 2011 updated by: Telik

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

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

Study Overview

Status

Completed

Conditions

Ovarian Neoplasms

Intervention / Treatment

Drug: TLK286

Study Type

Interventional

Enrollment

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Santa Monica, California, United States, 90404
    - Santa Monica Hematology/Oncology Consultants
- Illinois
  - Skokie, Illinois, United States, 60077
    - Midwest Cancer Research Group, Inc.
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana Farber Cancer Institute
  - Boston, Massachusetts, United States, 02215
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Beth Israel Deaconess Medical Center
- Texas
  - Houston, Texas, United States, 77030
    - M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 17, 2003

First Submitted That Met QC Criteria

January 21, 2003

First Posted (Estimate)

January 22, 2003

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

TLK286.2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.