Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea

NCT04589039CompletedOBSERVATIONAL

Summary

The purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered niraparib as per the approved indications.

Key Facts

Lead Sponsor

Takeda

Enrollment

662

Start Date

2020-03-16

Completion Date

2024-09-11

Study Type

OBSERVATIONAL

Official Title

Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea

Conditions

Ovarian Neoplasms

Eligibility

Age Range

19 Years+

Sex

FEMALE

Inclusion Criteria:

1. Monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
2. Monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy.
3. Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive.

Exclusion Criteria:

1. Treated with niraparib outside of the locally approved label in Korea.
2. Niraparib is contraindicated as per product label.
3. Participating in other clinical trials of cancer treatment.

Outcome Measures

Primary Outcomes

Percentage of Participants with AEs, SAEs, and AESIs

Time frame: Baseline up to 24 months

Secondary Outcomes

Time-to-Treatment Discontinuation (TTD)

TTD is defined as the time interval from the date of initiation of treatment until discontinuation of treatment, or death due to any cause, whichever occurs first. Participants who have not discontinued treatment, or died, will be censored at the last known time that the participant was on treatment.

Time frame: From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)

Progression Free Survival (PFS)

PFS is defined as the time interval from the date of initiation of treatment until objectively documented disease progression, or death due to any cause, whichever occurs first. Participants who do not have disease progression, or have not died, will be censored at the last known time that the participant was progression-free. Progressive disease (PD) is defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The determination of disease progression will be at the Investigators discretion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

Time frame: From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months)

Locations

Inje University Haeundae Paik Hospital, Busan, South Korea

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.