Clinical trials: Niraparib
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer.
- Trial name
- ProBio (NCT03903835)
- Testing
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin
- Where
- 32 sites in Belgium, Norway and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
Ovarian Cancer, Fallopian Tube Cancer
European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer
This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Trial name
- EUDARIO (NCT03783949)
- Testing
- Ganetespib, Niraparib, Carboplatin
- Where
- 13 sites in Austria, Belgium and 3 more
- Volunteers
- 122 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Ovarian Cancer
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the…
- Trial name
- NIRAPARIB (NCT06614790)
- Testing
- Niraparib 200/300 MG
- Where
- 12 sites in Poland
- Volunteers
- 300 people
- Sponsor
- Pomeranian Medical University Szczecin
Treatment Efficacy
Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer
A number of anti-PD-1/L1 monoclonal antibodies have been approved for the treatment of various advanced tumors in the world, and many studies on anti-PD-1 /L1 monoclonal antibodies for breast cancer are also being carried out.
- Trial name
- CHANGEABLE (NCT04508803)
- Testing
- HX008，Niraparib, HX008，Niraparib，Trastuzumab, HX008，Niraparib，Pyrrolitinib
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Fudan University
Thrombocytopenia
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
Niraparib brings a better prognosis to those with advanced ovarian cancer and has been approved by the Food and Drug Administration（FDA ）and National Medical Products Administration（NMPA）as one of the maintenance therapies for…
- Trial name
- NCT06036966
- Testing
- Hetrombopag
- Volunteers
- 34 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Advanced Ovarian Cancer
Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer
PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status.
- Trial name
- LIBINI-1 (NCT07059676)
- Testing
- Zejula (Niraparib)
- Volunteers
- 120 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Ovarian Cancer, Fallopian Tube Cancer
Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Trial name
- Newton (NCT03891576)
- Testing
- Niraparib
- Where
- 12 sites in Germany, Italy
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Glioblastoma, Glioblastoma Multiforme
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioma, GBM
- Trial name
- NCT05076513
- Testing
- Niraparib, Radiation therapy
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Nader Sanai
Cervical Cancer
Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer
A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and Persistent Cervical Cancer
- Trial name
- CQGOG0101 (NCT04395612)
- Testing
- niraparib combined with brivanib, niraparib combined with toripalimab
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Chongqing University Cancer Hospital
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.
Endometrial Cancer
Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose)…
- Trial name
- NCT03016338
- Testing
- Niraparib, TSR-042
- Where
- 7 sites in Canada
- Volunteers
- 51 people
- Sponsor
- University Health Network, Toronto
Ovarian Cancer, Fallopian Tube Cancer
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Trial name
- NCT05009082
- Testing
- Carboplatin, Paclitaxel, Bevacizumab
- Where
- 65 sites in Germany
- Volunteers
- 970 people
- Sponsor
- AGO Study Group
Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma
Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
This phase I/II trial tests the safety, side effects and best dose of a combination therapy (niraparib and selenium) in treating patients with BRCA negative ovarian cancer that has come back (recurrent) and does not respond to…
- Conditions
- Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT05672095
- Testing
- Biopsy, Biospecimen Collection, Niraparib
- Sponsor
- City of Hope Medical Center
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.
Head and Neck Squamous Cell Carcinoma
Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
Multi-center, open-label, non-randomized, non-comparative two-cohort study for patients with locally-advanced squamous cell carcinoma arising from the larynx, hypopharynx, oropharynx (Stage III, IVA and IVB according to 8th…
- Trial name
- RADIAN (NCT05784012)
- Testing
- Dostarlimab, Niraparib, cisplatin plus radiotherapy
- Where
- 7 sites in Spain
- Volunteers
- 34 people
- Sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Ovarian Cancer
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the…
- Trial name
- NCT06412120
- Testing
- Niraparib
- Where
- 4 sites in United States, Nigeria
- Volunteers
- 70 people
- Sponsor
- University of Miami
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
Ovarian Cancer
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical…
- Trial name
- CONOR (NCT05857397)
- Testing
- Observational study
- Where
- 16 sites in Argentina, Brazil
- Volunteers
- 64 people
- Sponsor
- Latin American Cooperative Oncology Group
Efficacy
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected…
- Trial name
- NCT06237205
- Testing
- Niraparib
- Volunteers
- 33 people
- Sponsor
- Korea University Anam Hospital