Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niraparib · 1 trial · 2 indications
for maintenance therapy arm
for maintenance therapy arm
| Arm | Type | Description |
|---|---|---|
| Niraparib as maintenance therapy for Endometrial Serous Carcinoma | EXPERIMENTAL | For patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate. |
| Niraparib as recurrent therapy for Endometrial Carcinoma | EXPERIMENTAL | For patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate. |
| Name | Type | Description |
|---|---|---|
| Niraparib | DRUG | Patients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression. |
Inclusion Criteria: * Women aged 18 or above * Histological confirmation of serous endometrial cancer or other types of endometrial cancer * FIGO stage III-IV * ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC p...
Niraparib is being studied as a monotherapy for the maintenance and recurrent treatment of endometrial serous carcinoma, a type of endometrial cancer. It is currently in Phase 2 clinical development for this indication, with an ongoing trial enrolling 83 female patients aged 18 years and older in China.
Niraparib is a PARP inhibitor, belonging to the -parib class of drugs. It targets poly (ADP-ribose) polymerase (PARP) enzymes, which are involved in DNA repair. By inhibiting PARP, Niraparib may interfere with cancer cell repair mechanisms, potentially leading to cell death in tumors with certain genetic biomarkers.
Niraparib is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting a Phase 2 clinical trial of Niraparib for endometrial serous carcinoma in China.
Niraparib is in Phase 2 clinical development for endometrial carcinoma, specifically for the maintenance and recurrent treatment of endometrial serous carcinoma. The drug is investigational and has not been approved for this indication. The ongoing Phase 2 trial is currently recruiting participants.
Niraparib is being evaluated in a single active Phase 2 clinical trial with the identifier NCT04716686. The trial, titled 'Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma,' is recruiting 83 female participants in China. The study is controlled but not randomized or double-blinded, and it uses biomarker selection.