This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.
This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.
Study Type
OBSERVATIONAL
Enrollment
300
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
RECRUITINGProgression free survival (PFS)
To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment
Time frame: up to two years
TFST
Time to first subsequent therapy
Time frame: up to two years
TSST
Time to second subsequent therapy
Time frame: up to two years
OS
Overall Survival
Time frame: up to two years
ORR
Overall Response Rate
Time frame: up to two years
Incidence of treatment-emergent adverse events
Toxicity will be evaluated by NCI CTCAE V 4.03
Time frame: up to two years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.