Clinical trial · Interventional
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)]
NCT00057720CI-TRIAL-00005268completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin HCl liposome injection | Drug | — | UNRESOLVED |
| TLK286 HCl for injection | Drug | — | UNRESOLVED |
| topotecan hydrochloride for injection | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.