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
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the effects of niraparib in those who have received neoadjuvant chemotherapy and subsequent interval debulking surgery, with or without hyperthermic intraperitoneal chemotherapy, and would also explore if there are any biomarkers, other than BRCA / HRD status and platinum sensitivity, that may help to identify those who may benefit from PARPi especially those who are HRD negative.
Despite cytoreductive surgery and platinum-based chemotherapy, about 70% of patients with advanced ovarian cancer recur in the first 2 - 3 years. PARPi has been shown to be prolong survival in primary advanced ovarian cancer. However its role in neoadjuvant setting has not been fully evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Niraparib 200 or 300mg daily orally for 18 cycles unless disease progression or intolerable side effects (whichever occurs first) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | PARP inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate at 18 months | Proportion of patients who are progression-free at 18 months according to the RECIST 1.1 | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS by the RECIST 1.1 | The time from first dose of trial medication to first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first. | up to 5 years |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ka Yu Tse, FRCOG | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545685 | niraparib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Overall survival is defined as the time from first dose of trial medication to date of death due to any cause.
| up to 5 years |
| OS rate at 18 months | Proportion of patients who are alive at 18 months | up to 18 months |
| Change of biomarkers | Expression levels of markers like Ki-67 before and after chemotherapy | up to 18 months |
| Treatment-related adverse events | Incidence of treatment-related adverse events classified by CTCAE version 5.0 | up to 18 months |
| 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 |