Niraparib

Generic Name: Niraparib

Brand Names: Zejula

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₀N_₄O

CAS Number: 1038915-60-4

Unique Ingredient Identifier: HMC2H89N35

Background: Niraparib is an orally active poly (ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells. Niraparib is selective towards PARP-1 and PARP-2. First approved by the FDA on March 27, 2017, niraparib is used to treat epithelial ovarian, fallopian tube, or primary peritoneal can...

Indication: Niraparib is indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
...

Associated Conditions: Advanced Epithelial Ovarian Cancer, Advanced Primary Peritoneal Carcinoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Advanced Fallopian Tubes Cancer

Associated Therapies: Maintenance therapy

Clinical Trials

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Phase 1

Not yet recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: LM-2417
Drug: Docetaxel
Drug: Toripalimab/Tirelizumab
Drug: Carboplatin
Drug: Niraparib
Drug: Lenvatinib

First Posted Date: 2024-11-11

Last Posted Date: 2024-11-11

Lead Sponsor: LaNova Medicines Limited

Target Recruit Count: 320

Registration Number: NCT06682780

Locations: 🇨🇳
FuDan University Shanghai Cancer Center, Shanghai, Shanghai, China

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Tuvusertib (M1774)
Drug: Lartesertib (M4076)
Drug: Niraparib

First Posted Date: 2024-05-29

Last Posted Date: 2024-11-26

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 60

Registration Number: NCT06433219

Locations: 🇪🇸
Hospital Universitario Ramon y Cajal - Servicio de Oncologia, Madrid, Spain
🇪🇸
Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid, Spain
🇨🇭
Kantonsspital Frauenfeld - 150509250, Frauenfeld, Switzerland

and more 18 locations

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Phase 4

Not yet recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Niraparib

First Posted Date: 2024-05-14

Last Posted Date: 2024-12-13

Lead Sponsor: University of Miami

Target Recruit Count: 70

Registration Number: NCT06412120

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Phase 3

Recruiting

Conditions: Glioblastoma
Brain Tumor
GBM
Brain Neoplasms, Adult, Malignant

Interventions: Drug: Temozolomide
Drug: Niraparib

First Posted Date: 2024-04-29

Last Posted Date: 2024-06-24

Lead Sponsor: Ivy Brain Tumor Center

Target Recruit Count: 450

Registration Number: NCT06388733

Locations: 🇺🇸
Ivy Brain Tumor Center, Phoenix, Arizona, United States

Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Phase 2

Not yet recruiting

Conditions: MMR-D/MSI-H Colorectal Cancers

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2024-04-15

Last Posted Date: 2024-08-07

Lead Sponsor: Ibrahim Halil Sahin

Target Recruit Count: 20

Registration Number: NCT06365970

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Niraparib and Temozolomide in Patients Glioblastoma

Phase 1

Not yet recruiting

Conditions: Glioma, Malignant

Interventions: Drug: Temodal
Drug: Niraparib

First Posted Date: 2024-02-14

Last Posted Date: 2024-02-14

Lead Sponsor: Armando Santoro, MD

Target Recruit Count: 86

Registration Number: NCT06258018

Locations: 🇮🇹
Istituto clinico humanitas, Rozzano, Mi, Italy

Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

Phase 2

Not yet recruiting

Conditions: Efficacy

Interventions: Drug: Niraparib

First Posted Date: 2024-02-01

Last Posted Date: 2024-02-01

Lead Sponsor: Korea University Anam Hospital

Target Recruit Count: 33

Registration Number: NCT06237205

ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors

Phase 1

Withdrawn

Conditions: Ovarian Cancer
Recurrent Solid Tumors

Interventions: Drug: ZEN003694
Drug: Niraparib

First Posted Date: 2023-12-08

Last Posted Date: 2024-10-11

Lead Sponsor: Haider Mahdi

Target Recruit Count: 26

Registration Number: NCT06161493

Locations: 🇺🇸
UPMC Magee Womens Hospital, Pittsburgh, Pennsylvania, United States

Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

Phase 2

Recruiting

Conditions: Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Interventions: Drug: Niraparib

First Posted Date: 2023-11-21

Last Posted Date: 2023-11-21

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 116

Registration Number: NCT06141265

Locations: 🇨🇳
Peking University Cancer Hospital, Beijing, Beijing, China

The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer

Completed

Conditions: Epithelial Ovarian Cancer

Interventions: Drug: Niraparib

First Posted Date: 2023-10-17

Last Posted Date: 2023-10-17

Lead Sponsor: Asan Medical Center

Target Recruit Count: 850

Registration Number: NCT06086665

Locations: 🇰🇷
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy