A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05021562
Collaborator
(none)
300
1
54.5
5.5

Study Details

Study Description

Brief Summary

The main aim of this study is to check for side effects from treatment with niraparib.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Zedula Special Drug Use Observational Study "Ovarian Cancer"
Actual Study Start Date :
Sep 13, 2021
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Niraparib 200-300 milligrams (mg)

Arm description: Niraparib 200 mg, capsules, orally, once daily. For adult participants weighing 77 kilograms (kg) or more and with platelet count 150,000/mcrL or higher before the first dose of this drug, niraparib 300 mg, capsules, orally, once daily.

Drug: Niraparib
Niraparib capsules

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Event of Myelosuppression [1 year]

    An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AE of myelosuppression will be reported.

  2. Number of Participants with Adverse Event of Hypertension [1 year]

    Number of participants with AE of hypertension will be reported.

  3. Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome [1 year]

    Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.

  4. Number of Participants with Adverse Event of Interstitial Lung Disease [1 year]

    Number of participants with AE of interstitial lung disease will be reported.

  5. Number of Participants with Adverse Event of Secondary Malignant Tumors [1 year]

    Number of participants with AE of secondary malignant tumors will be reported.

  6. Number of Participants with Adverse Event of Thromboembolism [1 year]

    Number of participants with AE of thromboembolism will be reported.

Secondary Outcome Measures

  1. Percentage of Participants Who Achieve or Maintain Any Best Overall Response Category in Population of Recurrent Ovarian Cancer Participants with Platinum-Sensitive Homologous Recombination Repair Defects [1 year]

    Percentage of participants who achieve or maintain any best overall response category best overall response in population of recurrent ovarian cancer participants with platinum-sensitive homologous recombination repair defects will be reported. Best overall response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best overall response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period.

  2. Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study [1 year]

    Exacerbation is defined as death or worsened symptom or disease assessed by investigator through tumor assessments, tumor marker assessments, and clinical assessments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
An individual who corresponds to any of the following:
  • Ovarian cancer patients after initial chemotherapy (maintenance therapy)

  • Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy)

  • Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

Exclusion Criteria:

Has a history of hypersensitivity to any of the ingredients of this drug.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Takeda Selected Site Tokyo Japan

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT05021562
Other Study ID Numbers:
  • Niraparib-4001
First Posted:
Aug 25, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021