Health Authority : United States Food and Drug Administration .
Official Title Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial) .
NCT02421588 .
Descriptive Information :
Brief Title Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients .
Brief 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).
Estimated Enrollment : 420
Data from the preceding phase II trial in these patients showed a progression-free survival of 5.7 months, which was significantly better compared to the 1.7 months achieved by patients treated with topotecan[i].
Arturo Soto, Director of Clinical Development at PharmaMar said, “Women with platinum-resistant ovarian cancer have poor prognosis and do not respond well to current therapies. PM1183 is a novel drug that works differently compared to other drugs used to treat this type of cancer.”
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