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

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ClinicalTrials.gov Identifier: NCT00057720
Recruitment Status : Completed
First Posted : April 8, 2003
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: TLK286 HCl for injection Drug: topotecan hydrochloride for injection Drug: doxorubicin HCl liposome injection Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Masking: None (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)]
Study Start Date : June 2003
Primary Completion Date : December 2006
Study Completion Date : December 2006


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057720


  Show 320 Study Locations
Sponsors and Collaborators
Telik
More Information

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
First Posted: April 8, 2003    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: May 2006

Keywords provided by Telik:
ovary

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Liposomal doxorubicin
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors