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

NCT00057720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2011-07-25

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

TLK286 HCl for injection

DRUG

topotecan hydrochloride for injection

DRUG

doxorubicin HCl liposome injection

Sponsors & Collaborators

  • Telik

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Chile
  • Czechia
  • Germany
  • Hungary
  • Ireland
  • Netherlands
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00057720 on ClinicalTrials.gov