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Ovarian CancerPhase 2NCT03759587

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

A Phase 2 study testing Niraparib in people with Ovarian Cancer and Fallopian Tube Cancer, run by Takeda at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older, women only
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
27 sitesJapan
Study dates
28 Dec 2018to 28 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.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.
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  • 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:
  • Absolute neutrophil count (ANC) ≥1,500/μL.
  • Platelet count ≥100,000/μL.
  • Hemoglobin ≥9 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.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN unless liver metastases were present, in which case they had to be ≤5×ULN.
  • Participants must be able to take oral medications.
  • Female participants of childbearing potential must be negative for pregnancy test (beta-human chorionic gonadotropin [β-hCG]) within 7 days prior to receiving the first dose of study treatment.
  • Female participants who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)

Who cannot join

  • 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.
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  • 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.
  • NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the study.
  • Participants who are immunocompromised (participants with splenectomy are allowed).
  • Participants who have known human immunodeficiency virus (HIV) positive.
  • Participants who have known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection.
  • NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must have an undetectable HCV viral load.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo

  • Chiba Cancer Center

    Chiba

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

  • Saitama Medical University International Medical Center

    Hidaka, Saitama

  • Hirosaki University Hospital

    Hirosaki, Aomori

  • Tokai University Hospital

    Isehara, Kanagawa

  • Kagoshima City Hospital

    Kagoshima

  • Nippon Medical School Musashi Kosugi Hospital

    Kawasaki, Kanagawa

  • Cancer Institute Hospital

    Koto-ku, Tokyo

  • Kurume University Hospital

    Kurume, Fukuoka

  • Kyoto University Hospital

    Kyoto

  • Shikoku Cancer Center

    Matsuyama, Ehime

  • The Jikei University Hospital

    Minato-ku, Tokyo

  • Iwate Medical University Hospital

    Morioka, Iwate

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka

  • Nagasaki University Hospital

    Nagasaki

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa

  • Niigata University Medical & Dental Hospital

    Niigata

  • Hokkaido University Hospital

    Sapporo, Hokkaido

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

  • Kindai University Hospital

    Sayama, Osaka

  • Tohoku University Hospital

    Sendai, Miyagi

  • Keio University Hospital

    Shinjuku-ku, Tokyo

  • Ehime University Hospital

    Tōon, Ehime

  • Mie University Hospital

    Tsu, Mie-ken

Other trials in Japan

About this study

Official title: 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

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.

Read the 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.

Being tested
Niraparib
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03759587
Study groupRoleWhat they receive
Niraparib 300 mgExperimentalNiraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 30 days after the first dose

Secondary outcomes (9)

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

    An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: 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).

  2. Number of Participants With Grade 3 or Higher TEAEs

    An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per 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 AE.

    Measured: 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).

  3. Number of Participants With Serious Adverse Events (SAEs)

    An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

    Measured: 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).

  4. Number of Participants With TEAEs Leading to Drug Discontinuation

    An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: 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).

  5. Number of Participants With TEAEs Leading to Dose Interruption

    An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: 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).

  6. Number of Participants With TEAEs Leading to Dose Reduction

    An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: 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).

  7. Progression Free Survival (PFS)

    PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.

    Measured: From first study drug administration until disease progression or death (up to 48 months)

  8. Overall Survival (OS)

    OS is defined as the time from the study enrollment to death due to any cause.

    Measured: Up to 48 months

  9. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start28 Dec 2018
  3. Primary completion17 Mar 2019
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03759587
Sponsor's protocol ID
Niraparib-2001
Other IDs
U1111-1222-4074, JapicCTI-184225
Status last verified
May 2024
First submitted
29 Nov 2018
Last updated
7 Jun 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • 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.

    PubMed 39058367

  • 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.

    PubMed 33470063

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Ovarian Cancer and Fallopian Tube Cancer, run by Takeda at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib (time frame: Up to 30 days after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03759587, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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