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

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00057720
First received: April 7, 2003
Last updated: July 21, 2011
Last verified: May 2006
History of Changes
  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 3

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:

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 May 21, 2013