Clinical trials: Niraparib
Neoplasms, Solid Tumors
A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)
This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.
- Trial name
- NCT01226901
- Testing
- MK-4827
- Volunteers
- 3 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Neoplasms, Triple Negative Breast Cancer
Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer.
- Conditions
- Neoplasms, Triple Negative Breast Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- TOPACIO (NCT02657889)
- Testing
- niraparib, pembrolizumab
- Where
- 30 sites in United States
- Volunteers
- 122 people
- Sponsor
- Tesaro, Inc.
Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
Study to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer.
- Conditions
- Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer
- Trial name
- NCT05335993
- Testing
- Oregovomab, Niraparib
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- CanariaBio Inc.
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
Ovarian Neoplasms
A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea
The purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered…
- Trial name
- NCT04589039
- Where
- South Korea
- Volunteers
- 662 people
- Sponsor
- Takeda
Solid Tumor
Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors
SYD985.004 is a two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib aimed at evaluating safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or…
- Trial name
- NCT04235101
- Testing
- SYD985 + Niraparib
- Where
- 6 sites in Belgium, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- Byondis B.V.
Ovarian Cancer, Fallopian Tube Cancer
Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT03759587
- Testing
- Niraparib
- Where
- 27 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Takeda
Neoplasms, Breast
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and…
- Trial name
- ZEST (NCT04915755)
- Testing
- Niraparib
- Where
- 198 sites in United States, Argentina and 25 more
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Neoplasms
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate…
- Trial name
- RUBY (NCT03981796)
- Testing
- Dostarlimab, Carboplatin, Paclitaxel
- Where
- 169 sites in United States, Belarus and 18 more
- Volunteers
- 785 people
- Sponsor
- Tesaro, Inc.
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
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
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 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 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
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.
Urothelial Carcinoma, Bladder Cancer
Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a…
- Trial name
- NCT03869190
- Testing
- Atezolizumab, Enfortumab Vedotin, Niraparib
- Where
- 33 sites in United States, France and 5 more
- Volunteers
- 272 people
- Sponsor
- Hoffmann-La Roche
Ovarian Cancer
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
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
- NCT04392102
- Testing
- ZL-2306(Niraparib）
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.