Clinical trials: Niraparib
Ovarian Cancer
Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer
This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of Huaier granules in combination with immunotargeted agents in postoperative patients with ovarian cancer.
- Trial name
- NCT05749211
- Testing
- Huaier granule
- Volunteers
- 59 people
- Sponsor
- Ruijin Hospital
Rectal Neoplasms, Rectal Neoplasm Malignant
A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer.
- Trial name
- NCT04926324
- Testing
- Niraparib, Dostarlimab, Short course radiation
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Iowa
Metastatic Breast Cancer, HER2 Positive Breast Carcinoma
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
- Trial name
- NCT03368729
- Testing
- Niraparib, Trastuzumab
- Where
- 7 sites in United States
- Volunteers
- 46 people
- Sponsor
- University of Alabama at Birmingham
Urothelial Bladder Cancer, Gastric Adenocarcinoma
Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab
Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles…
- Conditions
- Urothelial Bladder Cancer, Gastric Adenocarcinoma, Gastro-oesophageal Adenocarcinoma, Head and Neck Cancer
- Trial name
- NIRADO (NCT04779151)
- Testing
- Dostarlimab, Niraparib
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Ovarian Neoplasms, Neoplasms
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment…
- Conditions
- Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment
- Trial name
- NCT03359850
- Testing
- Niraparib
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Tesaro, Inc.
Ovarian Cancer, Recurrent Solid Tumors
ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors
This Phase I, open label, dose determining study of oral niraparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with metastatic or recurrent solid cancer.
- Trial name
- NCT06161493
- Testing
- ZEN003694, Niraparib
- Where
- United States
- Sponsor
- Haider Mahdi
Ovarian Cancer
A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer
Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer.
- Trial name
- NCT03895788
- Testing
- niraparib, Brivanib
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Hunan Cancer Hospital
OVARIAN CANCER
A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2). The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and…
- Trial name
- NCT03695380
- Testing
- Cobimetinib, Niraparib, Atezolizumab
- Where
- 20 sites in United States, Italy and 1 more
- Volunteers
- 77 people
- Sponsor
- Hoffmann-La Roche
Metastatic Solid Tumor, BRCA1 Mutation
Combination Therapy in Cancers With Mutations in DNA Repair Genes
The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy.
- Conditions
- Metastatic Solid Tumor, BRCA1 Mutation, BRCA2 Mutation, ATM Gene Mutation
- Trial name
- NCT05694715
- Testing
- Niraparib, Irinotecan
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
HER2-negative Breast Cancer, Gastric Adenocarcinoma
Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors
Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor.
- Conditions
- HER2-negative Breast Cancer, Gastric Adenocarcinoma, Cholangiocarcinoma, Pancreatic Cancer
- Trial name
- NCT04764084
- Testing
- Niraparib, Anlotinib
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Peking University Cancer Hospital & Institute
Epithelial Ovarian Cancer
Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed…
- Trial name
- RENI-1 (NCT04986371)
- Testing
- Niraparib
- Volunteers
- 300 people
- Sponsor
- Ling-Ying Wu
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.
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
MMR-D/MSI-H Colorectal Cancers
Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers
The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC.
- Trial name
- NCT06365970
- Testing
- Niraparib, Dostarlimab
- Sponsor
- Ibrahim Halil Sahin
Ovarian Cancer, Fallopian Tube Cancer
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT03759600
- Testing
- Niraparib
- Where
- 33 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Takeda
Ovarian Cancer, Fallopian Tube Cancer
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Clear Cell Carcinoma
- Trial name
- N-Plus (NCT05460000)
- Testing
- 3 cycles chemotherapy instead of 6 cycles chemotherapy, 6 cycles chemotherapy
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 640 people
- Sponsor
- North Eastern German Society of Gynaecological Oncology
Ovarian Neoplasms
A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)
The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC).
- Trial name
- NCT06964165
- Testing
- Niraparib, Carboplatin, Paclitaxel
- Where
- 21 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Tesaro, Inc.
Advanced Cancer, Metastatic Cancer
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: Find the recommended dose of ART4215 that can be given safely to participants…
- Conditions
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- Trial name
- NCT04991480
- Testing
- ART4215, Talazoparib, Niraparib
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 93 people
- Sponsor
- Artios Pharma Ltd
Recurrent Endometrial Serous Adenocarcinoma
Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma
This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent).
- Trial name
- NCT05870761
- Testing
- Biospecimen Collection, Computed Tomography, Dostarlimab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Casey Cosgrove
Ovarian Cancer
Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer
1. Study Introduction This non-interventional real-world study enrolls patients with ovarian cancer who receive niraparib as first-line maintenance therapy under routine clinical care.
- Trial name
- NCT07783022
- Testing
- Niraparib (Tablet)
- Where
- China
- Volunteers
- 1,920 people
- Sponsor
- Fudan University