TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer - Full Text View

TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.

Sponsored by:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00052065

Purpose

This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286	Phase I Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Further study details as provided by Telik:

Estimated Enrollment:	28
Study Start Date:	January 2003

Eligibility

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

Criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
Recurrent epithelial ovarian cancer or persistent disease following primary treatment
At least one, but no more than four, prior platinum-containing chemotherapy regimens
At least one prior taxane-containing regimen

Exclusion Criteria

A 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 the patient has been disease-free for 2 years
Known leptomeningeal metastases or carcinomatous meningitis
Have received prior Doxil or other liposomal doxorubicin
Having received whole pelvis radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052065

Locations


United States, Texas
	M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

Study ID Numbers:	TLK286.2011
First Received:	January 21, 2003
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00052065
Health Authority:	United States: Food and Drug Administration