Clinical trials: Niraparib
Advanced Solid Tumor
A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with…
- Trial name
- NCT06682780
- Testing
- LM-2417, Docetaxel, Toripalimab/Tirelizumab
- Where
- China
- Volunteers
- 320 people
- Sponsor
- LaNova Medicines Limited
Advanced Solid Tumor, Breast Cancer
Study of M4344 in Combination With Niraparib
Study will include 3 parts. Aim of Part 1 of this study is to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) for M4344 (is an Ataxia Telangiectasia Mutated and Rad3-related [ATR] inhibitors)…
- Trial name
- NCT04655183
- Testing
- Niraparib, M4344
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Ovarian Neoplasms, Breast Neoplasms
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within…
- Trial name
- NCT04641247
- Testing
- Niraparib
- Where
- 25 sites in United States, Austria and 6 more
- Volunteers
- 37 people
- Sponsor
- GlaxoSmithKline
Ovarian Neoplasms
Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid…
- Trial name
- MOONSTONE (NCT03955471)
- Testing
- Niraparib, Dostarlimab
- Where
- 27 sites in United States
- Volunteers
- 41 people
- Sponsor
- Tesaro, Inc.
HER2-negative Metastatic Breast Cancer
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: Part A is dose…
- Trial name
- NCT05261269
- Testing
- DAN-222, Niraparib
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dantari, Inc.
Neoplasms, Breast, Carcinoma of Breast
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
- Conditions
- Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation
- Trial name
- BRAVO (NCT01905592)
- Testing
- niraparib, Physician's choice
- Where
- 104 sites in United States, Belgium and 12 more
- Volunteers
- 216 people
- Sponsor
- Tesaro, Inc.
Ovarian Cancer, Platinum-resistant Ovarian Cancer
A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer
This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian…
- Conditions
- Ovarian Cancer, Platinum-resistant Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- NCT05198804
- Testing
- Azenosertib, Niraparib
- Where
- 22 sites in United States, France
- Volunteers
- 117 people
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Solid Tumor, Breast Tumor
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.
- Conditions
- Solid Tumor, Breast Tumor, Colon Tumor, Malignant, Lung Tumor
- Trial name
- PAVO (NCT05169437)
- Testing
- Niraparib
- Where
- 80 sites in United States
- Volunteers
- 22 people
- Sponsor
- Tempus AI
Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and…
- Trial name
- NCT01847274
- Testing
- Active comparator: Niraparib
- Where
- 112 sites in United States, Austria and 13 more
- Volunteers
- 596 people
- Sponsor
- Tesaro, Inc.
Ovarian Neoplasms
A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer
The goal of this clinical trial is to learn about the safety profile of niraparib in adult female participants for the treatment of advanced or relapsed epithelial ovarian cancer.
- Trial name
- NCT06887933
- Testing
- Niraparib
- Volunteers
- 67 people
- Sponsor
- GlaxoSmithKline
Gastric Cancer, Triple Negative Breast Cancer
A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or…
- Conditions
- Gastric Cancer, Triple Negative Breast Cancer, Biliary Tract Carcinoma, Endometrial Carcinoma
- Trial name
- NCT04178460
- Testing
- Niraparib combined with MGD013
- Where
- 19 sites in China
- Volunteers
- 60 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Ovarian Neoplasm
Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer
The primary objective of this sub study is to evaluate the efficacy of the combination of TSR-042, bevacizumab, and niraparib in participants with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal…
- Trial name
- COHORT-A (NCT05751629)
- Testing
- Dostarlimab, Bevacizumab, Niraparib
- Where
- 10 sites in United States
- Volunteers
- 41 people
- Sponsor
- Tesaro, Inc.
Prostatic Neoplasms
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult…
- Trial name
- NCT02924766
- Testing
- Niraparib, Apalutamide, Abiraterone Acetate
- Where
- 6 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Solid Tumors (Excluding Prostate Cancer), Ovarian Cancer
ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer
The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with elimusertib in combination with niraparib.
- Trial name
- NCT04267939
- Testing
- Elimusertib (BAY1895344), Niraparib
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Bayer
Metastatic Castration-resistant Prostate Cancer
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific…
- Trial name
- NCT05401214
- Testing
- Niraparib plus Abiraterone Acetate (Nira/AA) combination, Prednisone/Prednisolone
- Sponsor
- Janssen Research & Development, LLC
Castration-Resistant Prostatic Cancer
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
- Trial name
- MAGNITUDE (NCT03748641)
- Testing
- Niraparib, Abiraterone Acetate, Prednisone
- Where
- 318 sites in United States, Argentina and 27 more
- Volunteers
- 765 people
- Sponsor
- Janssen Research & Development, LLC
Extensive-stage Small Cell Lung Cancer
A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients…
- Trial name
- NCT03516084
- Testing
- ZL-2306(nirapairb)
- Where
- 33 sites in China
- Volunteers
- 185 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Prostatic Neoplasms
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination…
- Trial name
- AMPLITUDE (NCT04497844)
- Testing
- Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone
- Where
- 387 sites in United States, Argentina and 31 more
- Volunteers
- 696 people
- Sponsor
- Janssen Research & Development, LLC
Neoplasms, Metastatic Cancer
Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042
Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
- Conditions
- Neoplasms, Metastatic Cancer, Advanced Cancer, Solid Tumor
- Trial name
- NCT03307785
- Testing
- Niraparib, TSR-042, Carboplatin-Paclitaxel
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Tesaro, Inc.
Lung Cancer, Non-Small Cell
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung…
- Trial name
- ZEAL-1L (NCT04475939)
- Testing
- Niraparib, Pembrolizumab
- Where
- 188 sites in United States, Argentina and 25 more
- Volunteers
- 666 people
- Sponsor
- GlaxoSmithKline