Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| TFST | Time to first subsequent therapy | up to two years |
| TSST | Time to second subsequent therapy | up to two years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
No exclusion criteria
Not provided
Not provided
Not provided
Patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenica Lorusso, MD | Contact | 0630158545 | 0630158545 | domenica.lorusso@policlinicogemelli.it |
| Serena Giolitto, MSc | Contact | 0630158545 | 0630158545 | serena.giolitto@policlinicogemelli.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| OS | Overall Survival | up to two years |
| ORR | Overall Response Rate | up to two years |
| Incidence of treatment-emergent adverse events | Toxicity will be evaluated by NCI CTCAE V 4.03 | up to two years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |