Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

NCT03759600 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: Niraparib-2002U1111-1222-4100JapicCTI-184224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 33

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.

  Until disease progression or death (Up to 3.8 years)

Secondary Outcomes (10)

• Duration of Response (DOR)

  Until disease progression or death (Up to 3.8 years)

• Disease Control Rate (DCR)

  Until disease progression or death (Up to 3.8 years)

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

  From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)

• Number of Participants With Grade 3 or Higher TEAEs

  From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)

• Number of Participants With Serious TEAEs

  From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)

Study Arms (1)

Niraparib 300 mg

EXPERIMENTAL

Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib capsule

Niraparib 300 mg

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Female participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.
• 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.
• Participants must agree to undergo tumor homologous recombination deficiency/deficient (HRD) testing, and this test result must show that participants have an HRD-positive tumor (defined by the presence of a deleterious or suspected deleterious breast cancer gene (BRCA) mutation or be positive for genomic instability) by the central laboratory selected by the sponsor.
• Note 1: The study HRD test result must be received prior to enrollment. The tumor sample may be submitted for HRD testing prior to the screening period (ie, within 40 days before Cycle 1 Day 1) if the consent has been obtained and it appears the participant is likely to meet other eligibility requirements.
• Note 2: If historic blood germline BRCA mutation (gBRCAmut) is detected by a prior gBRCAmut testing, then tumor HRD sample test results are not required prior to enrollment; however, HRD testing still needs to be performed.
• Participants must have histologically diagnosed, relapsed, high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and have not experienced disease progression at least 6 months to the last chemotherapy containing platinum-based anticancer agents.
• Participants must have completed 3 or 4 previous chemotherapy regimens. Participants must have completed their last chemotherapy regimen \>4 weeks prior to treatment initiation.
• Participants must have at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1).
• 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:
• Absolute neutrophil count (ANC) ≥1,500/μL.
• Platelet count ≥150,000/μL.
• Hemoglobin ≥10 g/dL.
• Serum creatinine ≤1.5× institutional upper limit of normal (ULN) OR calculated creatinine clearance ≥50 mL/minute, using the Cockcroft-Gault equation.
• Total bilirubin ≤1.5×ULN OR direct bilirubin ≤1×ULN.

You may not qualify if:

• 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 known, persistent (\>4 weeks), Grade ≥3 hematologic toxicity from last cancer therapy.
• Participants who have any known, persistent (\>4 weeks), Grade ≥3 fatigue during the last cancer therapy.
• Participants who have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
• 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) inhibitors.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (33)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

The Jikei University Kashiwa Hospital

Kashiwa, Chiba, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Location

Ehime University Hospital

Tōon, Ehime, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, Japan

Location

Kure Medical Center and Chugoku Cancer Center

Kure, Hiroshima, 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

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Chiba Cancer Center

Chiba, Japan

Location

Chiba University Hospital

Chiba, Japan

Location

Gifu University Hospital

Gifu, 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)

• Aoki D, Tabata T, Yanagida S, Nakamura T, Kondo E, Hamanishi J, Harano K, Hasegawa K, Hirasawa T, Hori K, Komiyama S, Matsuura M, Nakai H, Nakamura H, Sakata J, Takehara K, Takekuma M, Yokoyama Y, Kase Y, Sumino S, Soeda J, Kato A, Suri A, Okamoto A, Sugiyama T. Niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer: final results of a multicenter phase 2 study. J Gynecol Oncol. 2024 Sep;35(5):e114. doi: 10.3802/jgo.2024.35.e114.

  PMID: 39251349 DERIVED

• Okamoto A, Kondo E, Nakamura T, Yanagida S, Hamanishi J, Harano K, Hasegawa K, Hirasawa T, Hori K, Komiyama S, Matsuura M, Nakai H, Nakamura H, Sakata J, Tabata T, Takehara K, Takekuma M, Yokoyama Y, Kase Y, Sumino S, Soeda J, Suri A, Aoki D, Sugiyama T. Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer. J Gynecol Oncol. 2021 Mar;32(2):e16. doi: 10.3802/jgo.2021.32.e16. Epub 2020 Dec 10.

  PMID: 33327047 DERIVED

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

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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 26, 2018
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: July 16, 2024
• Results First Posted: August 11, 2020

Record last verified: 2024-07

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 (33)