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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLK286

Drug

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Jan 23, 2003
Registry last updated: Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed