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Also known as Niraparib oral capsule
Niraparib · 1 trial · 1 indication
Progression free survival is defined as time from trial entry to evidence of progression of cancer at any site or death from any cause. Progression events should be imaging defined in all tumour types according to RECIST v1.1 criteria. Where SBRT specific consensus response assessment criteria exist for specific sites (e.g. spine), progression of SBRT treated lesions will be defined according to these guidelines.
| Arm | Type | Description |
|---|---|---|
| SBRT followed by Niraparib | OTHER | SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. Niraparib treatment will start 4 weeks post completion of SBRT treatment and will continue daily until disease progression or other discontinuation criteria are met. Niraparib comes in oral tablet form and the starting dose will be 200mg per day (once a day) or 300mg per day (once a day) calculated by participant's weight and platelet count. |
| SBRT alone | OTHER | SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. |
| Name | Type | Description |
|---|---|---|
| Niraparib oral capsule | DRUG | Niraparib used following SBRT treatment until disease progression |
| SBRT | RADIATION | SBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities. |
Inclusion Criteria: 1. Patients ≥ 18 years of age. 2. Histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer. (if cytology report includes immunohistochemistry confirming ovarian cancer, patient should not be excluded). 3. Radiological disease progression whilst on...
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Niraparib is an investigational small molecule being studied for recurrent ovarian cancer. It is being evaluated in a Phase 2 clinical trial for patients with oligometastases or oligoprogression following prior PARP inhibitor therapy. The drug is administered as an oral capsule and is not yet approved by the FDA.
Niraparib targets PARP, a class of enzymes involved in DNA repair. By inhibiting PARP, the drug may interfere with cancer cell repair mechanisms, potentially leading to cell death. This mechanism is being explored in the context of recurrent ovarian cancer, particularly after prior PARP inhibitor treatment.
Niraparib is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the drug's safety and efficacy in recurrent ovarian cancer.
Niraparib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. The ongoing Phase 2 trial is actively recruiting participants to assess its potential in recurrent ovarian cancer.
Niraparib is being studied in one active Phase 2 clinical trial with the identifier NCT05990192. The trial, titled 'SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy,' is recruiting female patients aged 18 years and older in the United Kingdom. The study has a target enrollment of 42 participants.
Yes, Niraparib oral capsule is the same drug as Niraparib. The oral capsule is the formulation being used in clinical trials. This alternative name is commonly used in trial documentation to specify the route of administration and dosage form.