29 junio 2015

PM01183 . PharmaMar Inicía la FASE III en Pacientes con Cáncer de Ovario Resistentes a Platinos en EEUU.

PharmaMar initiates the phase III study CORAIL for the anticancer agent PM1183 in patients with platinum-resistant ovarian cancer .


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) .


ClinicalTrials Identifier :
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.”

...