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

This study has been completed.

First Received on May 30, 2002. Last Updated on July 21, 2011 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00038428

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:	40
Study Start Date:	June 2001
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038428

Locations

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

No publications provided

Responsible Party:	Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier:	NCT00038428 History of Changes
Other Study ID Numbers:	TLK286.2003
Study First Received:	May 30, 2002
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 12, 2012