Clinical trials: Niraparib
Ovarian Cancer, Peritoneal Cancer
Real-life Use of Niraparib in a Patient Access Program in Norway
Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.
- Trial name
- NCT04785716
- Testing
- Niraparib
- Where
- Norway
- Volunteers
- 106 people
- Sponsor
- Kristina Lindemann
Ovarian Cancer, Oligometastatic Disease
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with…
- Conditions
- Ovarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor
- Trial name
- ANALLISA (NCT06180356)
- Testing
- Niraparib oral tablets
- Where
- 14 sites in Spain
- Volunteers
- 30 people
- Sponsor
- MedSIR
Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation
Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This phase Ib trial studies the best dose and side effects of niraparib and copanlisib in treating patients with endometrial, ovarian, primary peritoneal, or fallopian tube cancer that has come back.
- Conditions
- Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Endometrial Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma
- Trial name
- NCT03586661
- Testing
- Copanlisib, Niraparib
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- M.D. Anderson Cancer Center
Esophageal Cancer, Gastric Cancer
A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
Patients can be prescreened for the study at the time of diagnosis of locally advanced or metastatic disease by determining presence of LOH high status and/or deleterious alterations in HR pathway genes in the most recent…
- Conditions
- Esophageal Cancer, Gastric Cancer, Adenocarcinoma
- Trial name
- NCT03840967
- Testing
- Niraparib
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Shadia Jalal, MD
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
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
Metastatic Cancer, Central Nervous System Cancer
Niraparib in Tumors Metastatic to the CNS
This research is being done to see how effective the drug niraparib is against cancer that has metastasized to the central nervous system (CNS). This research study involves the study drug niraparib.
- Trial name
- NCT04992013
- Testing
- Niraparib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC)…
- Trial name
- BRAND (NCT06141265)
- Testing
- Niraparib
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Peking University Cancer Hospital & Institute
Platinum-sensitive Relapsed Ovarian Cancer
Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient
This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed…
- Trial name
- NCT03705156
- Testing
- ZL-2306(nirapairb)
- Where
- 27 sites in China
- Volunteers
- 265 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Lung Cancer, Mesothelioma
UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma…
- Trial name
- UNITO-001 (NCT04940637)
- Testing
- niraparib and dostarlimab
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- University of Turin, Italy
Ovarian Cancer
The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer
Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China…
- Trial name
- NCT03551171
- Testing
- ZL-2306 (niraparib)
- Where
- 6 sites in China
- Volunteers
- 42 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Solid Tumor, Adult, Homologous Recombination Deficiency
Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies
This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients with advanced, solid tumor malignancies who have pre-identified deleterious germline or somatic mutations in the homologous recombination…
- Trial name
- NCT03209401
- Testing
- Niraparib, Carboplatin
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- Georgetown University
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
Homologous Recombination Deficient Solid Tumors
Niraparib and Dostarlimab in HRD Solid Tumors
This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic, recurrent, or unresectable solid tumor with a…
- Trial name
- DIDO (NCT04983745)
- Testing
- Combination drug
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- West Cancer Center
Ovarian Neoplasms, Fallopian Tube Neoplasms
Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy.
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endocrine Gland Neoplasms, Neoplasms by Site
- Trial name
- AVANIRA3 (NCT04556071)
- Testing
- Niraparib, Bevacizumab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Xiaoxiang Chen
Ovarian Cancer
Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer
Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS) PARP inhibitors are active as monotherapy to treat patients with recurrent…
- Trial name
- AVANOVA (NCT02354131)
- Testing
- Niraparib, Bevacizumab
- Where
- 2 sites in United States, Denmark
- Volunteers
- 108 people
- Sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Recurrent Cervix Cancer, Progressive Cervix Cancer
Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix…
- Trial name
- STAR (NCT04068753)
- Testing
- Niraparib, dostarlimab
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- University of Oklahoma
Cancer: Solid Tumors
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel…
- Trial name
- NCT01110603
- Testing
- MK-4827, carboplatin, paclitaxel
- Volunteers
- 12 people
- Sponsor
- Tesaro, Inc.
Carcinoma, Endometrial Adenocarcinoma
PEN-866 in Patients With Advanced Solid Malignancies
Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
- Conditions
- Carcinoma, Endometrial Adenocarcinoma, Neoplasms, Squamous Cell Carcinoma of the Anus
- Trial name
- NCT03221400
- Testing
- PEN-866 Sodium, fluorouracil, Folinic acid
- Where
- 16 sites in United States
- Volunteers
- 340 people
- Sponsor
- Tarveda Therapeutics
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT05689021
- Testing
- Abiraterone Acetate/Niraparib, Biospecimen Collection, Bone Scan
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Mayo Clinic