Clinical trials: Niraparib
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.
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.
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 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.
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
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
Ovarian Neoplasms
A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer
This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal…
- Trial name
- OPAL (NCT03574779)
- Testing
- Niraparib, TSR-042, Bevacizumab
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 77 people
- Sponsor
- Tesaro, Inc.
Advanced Solid Tumor, Adult
Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib), in patients with eligible advanced solid tumors, determine the maximum tolerated dose…
- Trial name
- ATTACC (NCT04972110)
- Testing
- RP-3500 (camonsertib)
- Where
- 13 sites in United States
- Volunteers
- 156 people
- Sponsor
- Repare Therapeutics
Ovarian Neoplasms
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer.
- Trial name
- NCT02655016
- Testing
- Niraparib
- Where
- 116 sites in United States, Belgium and 12 more
- Volunteers
- 733 people
- Sponsor
- Tesaro, Inc.
Neoplasms
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer…
- Trial name
- NCT03308942
- Testing
- Niraparib, Pembrolizumab, TSR-042 (Dostarlimab)
- Where
- 16 sites in United States
- Volunteers
- 53 people
- Sponsor
- Tesaro, Inc.
Ovarian Neoplasms, Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression…
- Trial name
- FIRST (NCT03602859)
- Testing
- Niraparib, Dostarlimab (TSR-042), Standard of care
- Where
- 182 sites in United States, Belarus and 17 more
- Volunteers
- 1,400 people
- Sponsor
- Tesaro, Inc.
Ovarian Neoplasms, Ovarian Cancer
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens.
- Trial name
- QUADRA (NCT02354586)
- Testing
- Niraparib
- Where
- 55 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Tesaro, Inc.
Ovarian Neoplasms
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with…
- Trial name
- NCT03326193
- Testing
- Niraparib, Bevacizumab
- Where
- 29 sites in United States
- Volunteers
- 105 people
- Sponsor
- Tesaro, Inc.
Neoplasms, Breast
Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer…
- Trial name
- NCT03329937
- Testing
- Niraparib
- Volunteers
- 21 people
- Sponsor
- Tesaro, Inc.
Prostatic Neoplasms
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
- Trial name
- Galahad (NCT02854436)
- Testing
- Niraparib
- Where
- 110 sites in United States, Australia and 13 more
- Volunteers
- 289 people
- Sponsor
- Janssen Research & Development, LLC
Neoplasms, Triple Negative Breast Cancer
Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer.
- Conditions
- Neoplasms, Triple Negative Breast Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- TOPACIO (NCT02657889)
- Testing
- niraparib, pembrolizumab
- Where
- 30 sites in United States
- Volunteers
- 122 people
- Sponsor
- Tesaro, Inc.
Neoplasms
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the paediatric population.
- Trial name
- NCT04544995
- Testing
- Niraparib (Tablet for oral suspension), Dostarlimab, Niraparib (Tablet)
- Where
- 2 sites in United Kingdom
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline