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 an investigational small molecule being studied for the treatment of ovarian cancer and advanced solid tumors. In clinical trials, it has been evaluated as a single agent in participants with advanced solid tumors and as maintenance therapy in participants with relapsed ovarian cancer, including fallopian tube cancer and primary peritoneal cancer.
Niraparib is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted clinical trials of Niraparib in Japan for the treatment of ovarian cancer and advanced solid tumors.
Niraparib is in clinical development, with completed Phase 1 and Phase 2 trials. The Phase 1 trial studied Niraparib as a single agent in advanced solid tumors, and the Phase 2 trials studied Niraparib as maintenance therapy and in advanced, relapsed ovarian cancer. Niraparib is not approved and remains investigational.
Niraparib has been studied in three completed trials in Japan. NCT03497429 was a Phase 1 study of Niraparib as a single agent in advanced solid tumors. NCT03759587 was a Phase 2 study of Niraparib as maintenance therapy in relapsed ovarian cancer. NCT03759600 was a Phase 2 study of Niraparib in advanced, relapsed ovarian cancer.
Niraparib is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials in Japan for ovarian cancer and advanced solid tumors. The trials were completed, but approval status has not been established, and Niraparib remains in clinical development.
The Niraparib trials enrolled a total of 39 participants. The trials were not randomized or double-blind, and they used a controlled design. The Phase 1 trial enrolled 9 participants with advanced solid tumors, and the two Phase 2 trials enrolled 19 and 20 participants with ovarian cancer, respectively.