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

NCT03759587 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: Niraparib-2001U1111-1222-4074JapicCTI-184225
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib

  An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).

  Up to 30 days after the first dose

Secondary Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From the day of signing the informed consent form (ICF) until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).

• Number of Participants With Grade 3 or Higher TEAEs

  From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).

• Number of Participants With Serious Adverse Events (SAEs)

  From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).

• Number of Participants With TEAEs Leading to Drug Discontinuation

  From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).

• Number of Participants With TEAEs Leading to Dose Interruption

  From the day of signing the ICF until 30 days after last dose of study drug administration or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months).

Study Arms (1)

Niraparib 300 mg

EXPERIMENTAL

Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib capsule

Niraparib 300 mg

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Female participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible to be enrolled in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese female participants aged 20 years or older on the day of signing informed consent.
• 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.
• Participant must have a histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• 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).
• 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.
• 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.
• 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.
• Following the last regimen, participants must have had either: CA-125 in the normal range, OR; CA-125 decrease by more than 90% during the last platinum regimen, and which was stable for at least 7 days (ie, no increase \>15%).
• Following the last regimen, participants could not have had any measurable lesion \>2 cm at the time of study enrollment.
• Participants must have been enrolled within 8 weeks after completion of their final dose of the platinum-containing regimen.
• Participants must have performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale.
• Participants must have adequate organ function as indicated by the following laboratory values:

You may not qualify if:

• Participants who have had drainage of ascites during last 2 cycles of last chemotherapy.
• Participants who have had palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of the first dose of study treatment.
• Participants who have any, persistent, Grade ≥3 toxicity from last cancer therapy.
• 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.
• Participants who have known hypersensitivity to the components of niraparib.
• Participants who have had prior treatment with a known poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor.
• Participant who have had treatment with any investigational products within 28 days or 5 half-lives (whichever was longer) before the first dose.
• 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.
• 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.
• 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.
• Participants who have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
• Participants who have received a live virus or bacterial vaccines within 4 weeks of the first dose of study treatment.
• Participants who have a history or current evidence of any condition, therapy, or lab abnormality (including active or uncontrolled myelosuppression \[ie, anemia, leukopenia, neutropenia, thrombocytopenia\]) that might confound the results of the study, interfere with the participant's participation throughout the study period, or study participation is not in the best interest of the participant.
• Participants who are regular user (including "recreational use") of any illicit drugs at the time of signing informed consent or have a recent history (within the past year) of drug or alcohol abuse.
• Participants who are pregnant or breast-feeding, or expecting to conceive within the planned duration of the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (27)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Location

Ehime University Hospital

Tōon, Ehime, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, Japan

Location

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Kanagawa, Japan

Location

Mie University Hospital

Tsu, Mie-ken, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, Okinawa, Japan

Location

Kindai University Hospital

Sayama, Osaka, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Location

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Cancer Institute Hospital

Koto-ku, Tokyo, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Chiba Cancer Center

Chiba, Japan

Location

Kagoshima City Hospital

Kagoshima, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Japan

Location

Related Publications (2)

• Itamochi H, Takeshima N, Hamanishi J, Hasegawa K, Matsuura M, Miura K, Nagao S, Nakai H, Tanaka N, Tokunaga H, Nishio S, Watari H, Yokoyama Y, Kase Y, Sumino S, Kato A, Suri A, Yasuoka T, Takehara K. Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study. J Gynecol Oncol. 2024 Sep;35(5):e115. doi: 10.3802/jgo.2024.35.e115. Epub 2024 Jul 17.

  PMID: 39058367 DERIVED

• Takehara K, Matsumoto T, Hamanishi J, Hasegawa K, Matsuura M, Miura K, Nagao S, Nakai H, Tanaka N, Tokunaga H, Ushijima K, Watari H, Yokoyama Y, Kase Y, Sumino S, Suri A, Itamochi H, Takeshima N. Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer. J Gynecol Oncol. 2021 Mar;32(2):e21. doi: 10.3802/jgo.2021.32.e21. Epub 2021 Jan 6.

  PMID: 33470063 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: December 28, 2018
• Primary Completion: March 17, 2019
• Study Completion: December 28, 2022
• Last Updated: June 7, 2024
• Results First Posted: March 25, 2020

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (27)