Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cancer
- Interventions
- Registration Number
- NCT03759600
- Lead Sponsor
- Takeda
- 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.
- Detailed Description
The drug being tested in this study is called niraparib. Niraparib is being tested to treat people who have the homologous recombination deficiency (HRD)-positive, advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This study will look at the efficacy and safety of niraparib in Japanese participants.
The study will enroll approximately 16 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 23 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Niraparib 300 mg Niraparib Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Until disease progression or death (Up to 3.8 years) 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.
- Secondary Outcome Measures
Name Time Method 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) An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Number of Participants With TEAEs Leading to Drug Discontinuation 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) An AE was 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 was defined as an adverse event with an onset that occurs after receiving study drug.
Disease Control Rate (DCR) Until disease progression or death (Up to 3.8 years) DCR was defined as the percentage of participants achieving CR, PR or SD 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. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
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) An AE was 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 serious adverse event (SAE) was 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. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Duration of Response (DOR) Until disease progression or death (Up to 3.8 years) DOR was defined as the time from the first documented CR or PR per RECIST v.1.1 to disease recurrence or objective disease progression whichever occurs first. 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.
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) An AE was 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 was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (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.
Number of Participants With TEAEs Leading to Dose Interruption 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) An AE was 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 was defined as an adverse event with an onset that occurs after receiving study drug.
Number of Participants With TEAEs Leading to Dose Reduction 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) An AE was 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 was defined as an adverse event with an onset that occurs after receiving study drug.
Progression Free Survival (PFS) Until disease progression or death (Up to 3.8 years) PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of PD or death as assessed by the RECIST v.1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
Overall Survival (OS) 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) OS was defined as the time in months from the study enrollment to death due to any cause.
Trial Locations
- Locations (33)
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Nippon Medical School Musashi Kosugi Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
The Jikei University Kashiwa Hospital
🇯🇵Kashiwa, Chiba, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure, Hiroshima, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-cho, Shizuoka, Japan
Cancer Institute Hospital
🇯🇵Koto-ku, Tokyo, Japan
Toho University Omori Medical Center
🇯🇵Ota-ku, Tokyo, Japan
Kagoshima City Hospital
🇯🇵Kagoshima, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
University of the Ryukyus Hospital
🇯🇵Nakagami-gun, Okinawa, Japan