Loading clinical trials...

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Niraparib in Japanese Patients With Platinum-sensitive, Relapsed Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Achieved CR or PR in the Last Chemotherapy Containing Platinum-based Anticancer Agents

NCT03759587•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents.

Detailed Description

The drug being tested in this study is called niraparib. Niraparib is being tested to treat people who have platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study will look at the safety and efficacy of niraparib in Japanese participants. The study will enroll approximately 15 participants. Participants will be enrolled to one group and after that will be asked to take niraparib capsules at the same time each day throughout the study: \- Niraparib 300 mg This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 28 months. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.

Eligibility

Age

20 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Japanese female participants aged 20 years or older on the day of signing informed consent.
•2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
•3. Participant must have a histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
•4. Participant must have a high-grade (or Grade 3) serous or high-grade predominantly serous histology or known to have germline breast cancer gene mutation (gBRCAmut).
•5. Participants must have completed at least 2 previous lines of platinum-containing therapy (eg, carboplatin, oxaliplatin, or cisplatin):
•Note: The last platinum regimen did not necessarily have to immediately follow the next-to-last (penultimate) platinum regimen. For example, if a participant received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, she could have been eligible as long as she met all entry criteria.
•1. For the penultimate platinum-based chemotherapy prior to study enrollment, participants must have had platinum-sensitive disease after this treatment, defined as achieving a response (CR or PR) and disease progression \>6 months after completion of her last dose of platinum therapy (documented 6 to 12 months or \>12 months). Source documentation was required.
•2. For the last line of platinum-based chemotherapy prior to study enrollment:
•* Participants must have received a platinum-containing regimen for a minimum of 4 cycles.
•* Participants must have achieved a partial or complete tumor response.
+18 more criteria

Exclusion Criteria

•1. Participants who have had drainage of ascites during last 2 cycles of last chemotherapy.
•2. Participants who have had palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of the first dose of study treatment.
•3. Participants who have any, persistent, Grade ≥3 toxicity from last cancer therapy.
•4. Participants who have symptomatic, uncontrolled brain or leptomeningeal metastases. To be considered "controlled," central nervous system (CNS) disease must have undergone treatment (eg, radiation or chemotherapy) at least 1 month prior to study enrollment. The participant must not have had any new or progressive signs or symptoms related to the CNS disease and must have been taking a stable dose of steroids or no steroids (as long as these were started at least 4 weeks prior to enrollment\] or no steroids). A scan to confirm the absence of brain metastases at baseline was not required. Participants with spinal cord compression might have been considered if they had received definitive treatment for this and evidence of clinically stable disease for 28 days.
•5. Participants who have known hypersensitivity to the components of niraparib.
•6. Participants who have had prior treatment with a known poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor.
•7. Participant who have had treatment with any investigational products within 28 days or 5 half-lives (whichever was longer) before the first dose.
•8. Participants who have had major surgery per Investigator judgment within 3 weeks of the first dose. Participant must have recovered from any effects of any major surgery.
•9. Participants who have diagnosis, detection, or treatment of invasive second primary malignancy other than ovarian cancer ≤24 months prior to study enrollment (except basal or squamous cell carcinoma of the skin that was definitively treated). Note: Participants must not have any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), irrespective of the time for disease history.
•10. Participants who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the first dose) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, small bowel obstruction or other serious gastrointestinal disorder, or any psychiatric disorder that prohibits obtaining informed consent.
+10 more criteria

Locations (27)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Key Dates

Start Date

December 28, 2018

Primary Completion Date

March 17, 2019

Completion Date

December 28, 2022

Last Updated

June 7, 2024

Enrollment

ACTUAL participants

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Interventions

Niraparib

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)