Niraparib
- Generic Name
- Niraparib
- Brand Names
- Zejula
- Drug Type
- Small Molecule
- Chemical Formula
- C19H20N4O
- 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 cancer. Niraparib was approved by the European Commission on November 16, 2017 and by Health Canada on June 27, 2019.
- 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.
In Canada and the US, niraparib is also available in a combination product with abiraterone, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.
- 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
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
- Conditions
- Neoplasms, BreastBRCA2 Gene MutationCarcinoma of BreastHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastBRCA1 Gene MutationOvarian Neoplasms
- Interventions
- Drug: Physician's choice
- First Posted Date
- 2013-07-23
- Last Posted Date
- 2022-11-15
- Lead Sponsor
- Tesaro, Inc.
- Target Recruit Count
- 216
- Registration Number
- NCT01905592
- Locations
- 🇬🇧
GSK Investigational Site, Whitchurch, Cardiff, United Kingdom
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
- Conditions
- Ovarian NeoplasmsPlatinum Sensitive Ovarian Cancer
- Interventions
- Drug: placebo
- First Posted Date
- 2013-05-06
- Last Posted Date
- 2023-06-02
- Lead Sponsor
- Tesaro, Inc.
- Target Recruit Count
- 596
- Registration Number
- NCT01847274
- Locations
- 🇬🇧
GSK Investigational Site, Taunton, United Kingdom
Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)
- Conditions
- Recurrence of Solid TumorGlioblastoma MultiformeMelanoma
- Interventions
- First Posted Date
- 2011-02-11
- Last Posted Date
- 2012-08-15
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 19
- Registration Number
- NCT01294735
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
- First Posted Date
- 2010-11-19
- Last Posted Date
- 2016-11-06
- Lead Sponsor
- Tesaro, Inc.
- Registration Number
- NCT01244009
A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)
- First Posted Date
- 2010-10-22
- Last Posted Date
- 2012-06-28
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 3
- Registration Number
- NCT01226901
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
- Conditions
- Cancer: Solid Tumors
- Interventions
- First Posted Date
- 2010-04-26
- Last Posted Date
- 2016-05-05
- Lead Sponsor
- Tesaro, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT01110603
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
- Conditions
- HER2-negative Breast CancerHormone Receptor Positive TumorAngiosarcomaTNBC - Triple-Negative Breast CancerBreast NeoplasmsBreast TumorsHER2-positive Breast CancerHormone Receptor Negative TumorBreast CancerEarly-stage Breast Cancer
- Interventions
- Drug: Standard TherapyDrug: AMG 386 with or without TrastuzumabDrug: AMG 479 (Ganitumab) plus MetforminDrug: SYD985 ([vic-]trastuzumab duocarmazine)Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabDrug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabDrug: Datopotamab deruxtecan + DurvalumabDrug: Rilvegostomig + TDXdDrug: AMG 386 and Trastuzumab
- First Posted Date
- 2010-01-05
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- QuantumLeap Healthcare Collaborative
- Target Recruit Count
- 5000
- Registration Number
- NCT01042379
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸University of Texas, Southwestern Medical Center, Dallas, Texas, United States
🇺🇸University of Kansas, Westwood, Kansas, United States
A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)
- Conditions
- Solid TumorsChronic Lymphocytic LeukemiaT-cell-prolymphocytic Leukemia
- Interventions
- First Posted Date
- 2008-09-09
- Last Posted Date
- 2013-07-25
- Lead Sponsor
- Tesaro, Inc.
- Target Recruit Count
- 113
- Registration Number
- NCT00749502
Drug Development Updates
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