Clinical trials: Niraparib
Prostate Cancer, Castrate Resistant Prostate Cancer
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
This is an open-label, multicenter, interventional study in racially self-identified black or ethnically self-identified hispanic and racially self-identified white or native American participants with metastatic…
- Conditions
- Prostate Cancer, Castrate Resistant Prostate Cancer, Homologous Recombination Deficiency
- Trial name
- REPRESENTATION (NCT06527690)
- Testing
- Niraparib/Abirate rone acetate fixed-dose combination, Prednisone
- Sponsor
- Latin American Cooperative Oncology Group
Epithelial Ovarian Cancer, Ovarian Cancer
PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer
This study is the phase IV, open-label, clinical trial to determine the efficacy of niraparib maintenance therapy in BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients.
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Trial name
- POLO (NCT05187208)
- Testing
- Niraparib
- Volunteers
- 102 people
- Sponsor
- Seoul National University Hospital
Advanced Solid Tumor, Ovarian Cancer
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1.
- Trial name
- iNNOVATE (NCT04502602)
- Testing
- Neratinib 160 mg, Neratinib 200 mg, Neratinib 240 mg
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Virginia Commonwealth University
Breast Cancer, Breast Cancer Metastatic
Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
This study evalues the efficacy -as determined by the clinical benefit rate (CBR)- of niraparib in combination with AIs in unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer patients harboring…
- Trial name
- LUZERN (NCT04240106)
- Testing
- Niraparib, Aromatase Inhibitors
- Where
- 10 sites in Spain
- Volunteers
- 14 people
- Sponsor
- MedSIR
Metastatic Colorectal Cancer
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
Colorectal Cancer ranks third among the most frequent malignancies representing a leading cause of cancer-related death worldwide.
- Trial name
- Bohème (NCT05412706)
- Testing
- Niraparib
- Sponsor
- Ospedale Policlinico San Martino
Cancer
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during…
- Trial name
- IMbrella B (NCT03768063)
- Testing
- Atezolizumab, Bevacizumab, Alectinib
- Where
- 80 sites in United States, Australia and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Neoplasms
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the…
- Trial name
- NCT03329001
- Testing
- Niraparib Tablet, Niraparib Capsule
- Where
- 16 sites in United States
- Volunteers
- 236 people
- Sponsor
- Tesaro, Inc.
Ovarian Cancer
A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
The main aim of this study is to check for side effects from treatment with niraparib. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what…
- Trial name
- NCT05021562
- Testing
- Niraparib
- Where
- Japan
- Volunteers
- 354 people
- Sponsor
- Takeda
Recurrent/ Advanced Stage Endometrial Cancer Patients
An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1（Programmed Cell Death Protein 1） Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients
Endometrial carcinoma is the most common malignancy of the female reproductive tract. Most cases are diagnosed at an early stage due to the appearance of symptoms such as postmenopausal bleeding.
- Trial name
- NCT04885413
- Testing
- Niraparib in Combination With Anti-PD1 Antibody
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Sun Yat-sen University
Prostatic Neoplasms, Castration-Resistant
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative…
- Trial name
- QUEST (NCT03431350)
- Testing
- Niraparib 200 mg, Cetrelimab 240 mg, Cetrelimab 480 mg
- Where
- 50 sites in United States, Belgium and 5 more
- Volunteers
- 136 people
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Squamous Cell of Head and Neck
Biomarker-based Study in R/M SCCHN
This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy.
- Trial name
- UPSTREAM (NCT03088059)
- Testing
- Afatinib, Palbociclib, standard of care
- Where
- 36 sites in Belgium, France and 3 more
- Volunteers
- 340 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Ovarian Cancer, Stage III Ovarian Cancer
Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer.
- Conditions
- Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, High Grade Ovarian Serous Adenocarcinoma
- Trial name
- NCT05961124
- Testing
- Niraparib
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Sunnybrook Health Sciences Centre
Recurrent Endometrial Carcinoma, Recurrent Ovarian Carcinoma
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation
The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with…
- Conditions
- Recurrent Endometrial Carcinoma, Recurrent Ovarian Carcinoma, ARID1A Gene Mutation
- Trial name
- NCT05523440
- Testing
- Bevacizumab, Niraparib
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of Oklahoma
Metastatic Melanoma
Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
This open-label phase II trial studies how well niraparib works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.
- Trial name
- NCT03925350
- Testing
- Niraparib
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- California Pacific Medical Center Research Institute
Cancer
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.
- Trial name
- NCT04774406
- Testing
- olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
- Where
- France
- Volunteers
- 2,336 people
- Sponsor
- University Hospital, Caen
Recurrent Glioblastoma, Recurrent Astrocytoma
PARP Inhibition for Gliomas (PI-4G or π4g)
The purpose of this study is to determine what effects (good and bad) niraparib has on patients with recurrent brain cancer.
- Conditions
- Recurrent Glioblastoma, Recurrent Astrocytoma, Recurrent Oligodendroglioma, Recurrent Glioma
- Trial name
- OU-SCC-PI-4G (NCT05297864)
- Testing
- Niraparib
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Oklahoma
Locally Advanced Leiomyosarcoma, Metastatic Leiomyosarcoma
Niraparib for the Treatment of Leiomyosarcoma
This phase II trial tests whether niraparib works to shrink tumor in patients with leiomyosarcoma. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged.
- Conditions
- Locally Advanced Leiomyosarcoma, Metastatic Leiomyosarcoma, Stage III Retroperitoneal Sarcoma AJCC v8, Stage IIIA Retroperitoneal Sarcoma AJCC v8
- Trial name
- NCT05174455
- Testing
- Niraparib Tosylate Monohydrate
- Sponsor
- David Liebner, MD
Cancer, Tumors
The Drug Rediscovery Protocol (DRUP Trial)
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a…
- Conditions
- Cancer, Tumors, Neoplasm, Neoplasia
- Trial name
- DRUP (NCT02925234)
- Testing
- Panitumumab, Olaparib, Dabrafenib
- Where
- 36 sites in Netherlands
- Volunteers
- 1,550 people
- Sponsor
- The Netherlands Cancer Institute
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
Epithelial Ovarian Cancer, Ovarian Cancer
Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Trial name
- OVATION-3 (NCT06915025)
- Testing
- IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer), Paclitaxel, Carboplatin
- Where
- 10 sites in United States
- Volunteers
- 500 people
- Sponsor
- Imunon