TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Completed

Looking for future studies?

Notify Me

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 3

Primary location

Hospital Italiano Regional del Sur, Bahía Blanca, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

include:

Considered platinum refractory or resistant according to standard criteria
Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin
Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
Measurable disease according to RECIST criteria with documented tumor progression

Exclusion criteria

include:

Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
History of whole pelvis radiation therapy within 12 months of enrollment
Clinically significant cardiac disease
Evidence of gross hematuria at the time of study entry
Any signs of intestinal obstruction interfering with nutrition at the time of study entry
Pregnant or lactating women

Treatment and study plan

TLK286 HCl for injection

Drug

topotecan hydrochloride for injection

Drug

doxorubicin HCl liposome injection

Drug

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Apr 8, 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