Clinical trial · Interventional
TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]
- 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 research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin HCl Liposome Injection | Drug | — | UNRESOLVED |
| TLK286 in Combination with Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TLK286 in Combination with Carboplatin
- interventionNames
- Drug: TLK286 in Combination with Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Doxorubisin HCl Liposome Injection
- interventionNames
- Drug: Doxorubicin HCl Liposome Injection
Primary outcomes (1)
- measure
- Study Objectives
- timeFrame
- Every 8 Weeks
- description
- To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Are a woman 18 years of age or older * Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer * Have platinum refractory or resistant cancer * Measurable disease according to radiographic RECIST criteria with documented tumor progression Exclusion Criteria: * Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin) * Have clinically significant cardiac disease * Have any sign of intestinal obstruction interfering with nutrition at the time of study entry * Are pregnant or lactating * Had prior treatment with liposomal doxorubicin for ovarian cancer * Had prior treatment with TLK286
References
Publications (1)
- DERIVEDNewhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. PMID 37407274