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

This study has been completed.

First Received on April 7, 2003. Last Updated on July 21, 2011 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00057720

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286 HCl for injection Drug: topotecan hydrochloride for injection Drug: doxorubicin HCl liposome injection	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official 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)]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:	440
Study Start Date:	June 2003
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057720

Show 320 Study Locations

Sponsors and Collaborators

Telik

More Information

No publications provided

Responsible Party:	Gail Brown, MD Chief Medical Officer, Telik, Inc
ClinicalTrials.gov Identifier:	NCT00057720 History of Changes
Obsolete Identifiers:	NCT00078884
Other Study ID Numbers:	TLK286.3017
Study First Received:	April 7, 2003
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Telik:

ovary

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

Doxorubicin
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012