Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer
- Conditions
- Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
- Interventions
- Registration Number
- NCT03759587
- Lead Sponsor
- Takeda
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Niraparib 300 mg Niraparib Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle (up to 51 cycles).
- Primary Outcome Measures
Name Time Method Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib Up to 30 days after the first dose 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).
- Secondary Outcome Measures
Name Time Method 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). 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.
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). 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.
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). 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.
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). 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.
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). 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.
Number of Participants With TEAEs Leading to Dose Reduction 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). 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.
Progression Free Survival (PFS) From first study drug administration until disease progression or death (up to 48 months) 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.
Overall Survival (OS) Up to 48 months OS is defined as the time from the study enrollment to death due to any cause.
Overall Response Rate (ORR) Up to 48 months 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.
Trial Locations
- Locations (27)
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Kagoshima City Hospital
🇯🇵Kagoshima, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Cancer Institute Hospital
🇯🇵Koto-ku, Tokyo, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Nippon Medical School Musashi Kosugi Hospital
🇯🇵Kawasaki, Kanagawa, Japan
University of the Ryukyus Hospital
🇯🇵Nakagami-gun, Okinawa, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-cho, Shizuoka, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan