Trials / Completed
CompletedNCT00057720
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)]
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (planned)
- Sponsor
- Telik · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TLK286 HCl for injection | |
| DRUG | topotecan hydrochloride for injection | |
| DRUG | doxorubicin HCl liposome injection |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2003-04-08
- Last updated
- 2011-07-25
Locations
320 sites across 13 countries: United States, Argentina, Belgium, Brazil, Chile, Czechia, Germany, Hungary, Ireland, Netherlands, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00057720. Inclusion in this directory is not an endorsement.