Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niraparib · 3 trials · 4 indications
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).
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.
DLT was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03 and defined as any of the following events occurring during Cycle 1 that were considered by investigator to be related with niraparib: Any Grade 5 or 4 hematologic toxicity, except Grade 4 neutropenia less than (\<) 7 days; Grade 3 or 4 neutropenia with fever greater than (\>) 38.5 degree Celsius and/or infection requiring antibiotic/anti-fungal treatment; Any Grade 3, 4,or 5 non-hematologic toxicity except: Grade 3 nausea, vomiting, diarrhea/dehydration occurring in setting of inadequate compliance with supportive care and lasting \<48 hours, Inadequately treated hypersensitivity reactions, Grade 3 acidosis/alkalosis that responded to intervention by improving to less than or equal to (\<=) Grade 2 within 48 hours, Isolated asymptomatic Grade 3 amylase elevation, hypercholesterolemia and hypertriglyceridemia; Any TEAE leading to an interruption of niraparib for \>14 days.
TEAEs were graded as per the NCI-CTCAE version 4.03. As per the NCI-CTCAE, Grade 1 (mild, asymptomatic or mild symptoms); Grade 2 (moderate, minimal, local or noninvasive intervention indicated); Grade 3 (severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (life-threatening consequences, urgent intervention indicated); Grade 5 (death related to adverse event \[AE\]).
| Arm | Type | Description |
|---|---|---|
| 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). |
| Cohort 1: Niraparib 200 mg | EXPERIMENTAL | Niraparib 200 milligrams (mg), capsule, once orally on Days 1 - 21 of each 21-day treatment cycle. |
| Cohort 2: Niraparib 300 mg | EXPERIMENTAL | Niraparib 300 mg, capsule, once orally on Days 1 - 21 of each 21-day treatment cycle. |
| Name | Type | Description |
|---|---|---|
| Niraparib | DRUG | Niraparib capsule |
Inclusion Criteria 1. Japanese female participants aged 20 years or older on the day of signing informed consent. 2. 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 t...
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Niraparib is a small molecule oncology drug being developed by Takeda Pharmaceutical Company Limited. It is under study for advanced solid tumors and ovarian cancer, including fallopian tube and primary peritoneal cancer. Niraparib is an investigational agent in clinical development and is not described as approved.
Niraparib targets PARP1 and PARP2. It is classified as an inhibitor of these poly (ADP-ribose) polymerase enzymes. By binding PARP1 and PARP2, niraparib interferes with their activity in tumor cells, which is the basis for its study in advanced solid tumors and ovarian cancer.
Niraparib has been studied in ovarian cancer, including relapsed disease and maintenance therapy after response to prior treatment. Trials have also enrolled patients with fallopian tube cancer and primary peritoneal cancer. These studies were conducted in Japan in adult women aged 20 years and older.
Niraparib is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical studies evaluating niraparib in advanced solid tumors and ovarian cancer.
Niraparib has been evaluated in completed studies including NCT03759600, a Japan Phase 2 study in advanced relapsed ovarian cancer, NCT03759587, a Japan Phase 2 maintenance therapy study in relapsed ovarian cancer, and NCT03497429, a Phase 1 study as a single agent in advanced solid tumors.
Niraparib is in clinical development, with Phase 1 status for advanced solid tumors and Phase 2 studies completed in ovarian cancer. The completed trials include NCT03497429 in advanced solid tumors and two Japan Phase 2 ovarian cancer studies, NCT03759600 and NCT03759587.