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COMPLETEDPHASE3

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

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)]

NCT00057720•Telik

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

•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

Locations (320)

Little Rock Hematology Oncology Associates

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Southern California Permanente Medical Group

Baldwin Park, California, United States

Providence Saint Joseph Medical Center

Burbank, California, United States

Marilyn Norton, M. D.

Chula Vista, California, United States

Rosalba Rodriguez, M. D.

Chula Vista, California, United States

Bay Area Research Cancer Group

Concord, California, United States

Southwest Cancer Care

Escondido, California, United States

California Oncology of the Central Valley

Fresno, California, United States

Kaiser Permanente Oncology Clinical Trials Program

Hayward, California, United States

Key Dates

Start Date

June 1, 2003

Primary Completion Date

December 1, 2006

Completion Date

December 1, 2006

Last Updated

July 25, 2011

Enrollment

440

Estimated participants

Conditions

Ovarian Neoplasms

Interventions

TLK286 HCl for injection

DRUG

topotecan hydrochloride for injection

DRUG

doxorubicin HCl liposome injection

DRUG

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

NCT06051695

Solid Tumor, AdultColorectal Cancer+18 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

Establishment of a Tumor Bank for Tissue Samples

Institut Paoli Calmettes Ovarian Cancer Database