Corail Trial: Randomized Phase Iii Study Of Lurbinectedin (Pm01183) Versus Pegylated Liposomal Doxorubicin (Pld) Or Topotecan (T) In Patients With Platinum-Resistant Ovarian Cancer.

TPS5597Background: PM01183 (PM; lurbinectedin) is a new anticancer drug that blocks trans-activated transcription, induces DNA double-strand breaks and inhibits the tumor microenvironment. Significant activity (30% objective response rate) was reported in a phase II trial in patients (pts) with platinum-resistant ovarian cancer (ASCO 2014, oral session, abstract 5505). The most common toxicity observed was hematologic, mainly neutropenia. Methods: Multinational, multicenter (112 sites), open-label, randomized, phase III study of PM (3.2 mg/m2 1-h i.v. infusion, q3wk; experimental arm) vs. a control arm with either PLD (50 mg/m2, q4wk) or T (1.5 mg/m2, q3wk). A total of 420 pts will be randomized (1:1) and stratified according to performance status (PS), platinum-free interval (PFI) and number of prior chemotherapy lines. Interim safety (80 pts recruited) and futility (210 pts recruited) analysis are to be performed by an independent data monitoring committee. The most relevant inclusion criteria are: pts ...