Clinical trials: Niraparib
Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries.
- Trial name
- NIRAPK (NCT04861181)
- Testing
- Pharmacokinetics, Dosage of Niraparib
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Hospices Civils de Lyon
Prostate Cancer
A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with…
- Trial name
- NCT07477756
- Where
- United States
- Volunteers
- 1,247 people
- Sponsor
- Novartis Pharmaceuticals
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.
Neoplasms
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc).
- Trial name
- NCT06077877
- Testing
- GSK4524101, Niraparib
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
Homologous Recombination Deficiency, Triple Negative Breast Cancer
Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency
The incidence of homologous recombination deficiency in metastatic triple negative breast cancer was 52%-59%，PARP plays a key role in sensing DNA damage and converting it into intracellular signals that activate the base excision…
- Trial name
- NCT05461690
- Testing
- Niraparib
- Volunteers
- 50 people
- Sponsor
- Zhejiang Cancer Hospital
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
Breast Cancer, Triple Negative Breast Cancer
Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer
This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy (RT) is safe and effective in participants with metastatic triple negative breast cancer.
- Trial name
- NADiR (NCT04837209)
- Testing
- Niraparib, Dostarlimab, Radiation therapy
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
Epithelial Ovarian Cancer
A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer…
- Trial name
- t (NCT05385068)
- Testing
- Niraparib
- Volunteers
- 35 people
- Sponsor
- Peking Union Medical College Hospital
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, BRCA-Associated Malignant Neoplasm, BRCA Hereditary Ovarian Carcinoma
- Trial name
- NCT04673448
- Testing
- Dostarlimab, Niraparib, Biopsy
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Washington
Ovarian Cancer
Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.
Ovarian cancer is the second fatal gynecological cancer. More than 70% of ovarian cancer patients are diagnosed as advanced. Niraparib was approved by the National Medical Products Administration on December 27, 2019.
- Trial name
- NCT05583799
- Volunteers
- 222 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Ovarian Neoplasms
Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China.
- Trial name
- NCT05734911
- Testing
- Niraparib
- Where
- China
- Volunteers
- 199 people
- Sponsor
- Zhongda Hospital
Advanced Malignant Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy
This phase Ib/II trial studies the best dose of temozolomide and how well it works with niraparib and atezolizumab in treating patients with solid tumors that have spread to other places in the body (advanced) and extensive-stage…
- Conditions
- Advanced Malignant Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
- Trial name
- NCT03830918
- Testing
- Atezolizumab, Niraparib, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Jonsson Comprehensive Cancer Center
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 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.
Recurrent Ovarian Cancer
Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
- Trial name
- NCT03025867
- Testing
- Niraparib
- Sponsor
- Tesaro, Inc.
Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders
Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer
Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims…
- Conditions
- Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders, Medicine, Chinese Traditional, Chinese Herbal Medicine
- Trial name
- NCT07550205
- Testing
- Tiaoshen Anti-cancer Granules, Cognitive Behavioral Therapy for Insomnia, Standard First-line Platinum-based Chemotherapy
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
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.
Lymphoma, Mantle-Cell
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.
- Trial name
- NCT01244009
- Testing
- MK-4827
- Sponsor
- Tesaro, Inc.
Sarcoma,Soft Tissue, Sarcoma Uterus
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA
The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations.
- Trial name
- NCT05515575
- Testing
- Niraparib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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