drugset / Trial / NCT02421588
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
Timeline
- Start
- 2015-05
- Primary completion
- 2018-10-12
- Completion
- 2018-10-12
Outcome
Missed primary endpoint
registry analysis (superiority test); Lurbinectedin vs Control (PLD or Topotecan); p = 0.6294; Hazard Ratio (HR) 1.057 (95% CI 0.854 to 1.309); Log Rank NCT02421588 ↗
paper The primary endpoint of improvement in PFS was not met. PMID 34521554 ↗
Publications
- Newhouse 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.
- Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1.5 mg/m2 | Intravenous |