Olaparib

Generic Name
Olaparib
Brand Names
Lynparza
Drug Type
Small Molecule
Chemical Formula
C24H23FN4O3
CAS Number
763113-22-0
Unique Ingredient Identifier
WOH1JD9AR8
Background

Olaparib is a selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP1 and PARP2. PARP inhibitors represent a novel class of anti-cancer therapy and they work by taking advantage of a defect in DNA repair in cancer cells with BRCA mutations and inducing cell death.

Olaparib is used to treat a number of BRCA-associated tumours, including ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It was first approved by the FDA and EU in December 2014, and by Health Canada in April 2016.

Indication

Ovarian cancer

Olaparib is indicated for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

Olaparib is indicated in combination with bevacizumab for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

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

Breast cancer

Olaparib is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

Olaparib is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR) positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.

Pancreatic cancer

Olaparib is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Prostate cancer

Olaparib is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a hormone agent, such as enzalutamide or abiraterone.

It is also indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Associated Conditions
Advanced Epithelial Ovarian Cancer, Advanced Fallopian Tube Carcinoma, Advanced Primary Peritoneal Carcinoma, High risk, early breast cancer, Hormone Receptor Positive Breast Carcinoma, Locally Advanced Breast Cancer (LABC), Metastatic Adenocarcinoma of the Pancreas, Metastatic Breast Cancer, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Pancreatic Adenocarcinoma Metastatic, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Stage I Breast Cancer, Advanced high-grade epithelial ovarian cancer, Advanced, high-grade Primary Peritoneal Cancer, High-grade advanced Fallopian Tubes Cancer, Recurrent platinum sensitive primary peritoneal cancer, Relapsed Platinum-Sensitive Epithelial Ovarian Cancer, Relapsed platinum sensitive primary peritoneal cancer, Relapsed platinum-sensitive fallopian tube cancer
Associated Therapies
Maintenance therapy

Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

First Posted Date
2019-09-11
Last Posted Date
2024-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
42
Registration Number
NCT04086485
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-09-03
Last Posted Date
2024-07-29
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
29
Registration Number
NCT04076579
Locations
🇺🇸

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss

First Posted Date
2019-08-22
Last Posted Date
2024-07-11
Lead Sponsor
Institute of Cancer Research, United Kingdom
Target Recruit Count
174
Registration Number
NCT04065269
Locations
🇬🇧

Royal United Hospital, Bath, United Kingdom

🇬🇧

Western General Hospital, Edinburgh, United Kingdom

🇬🇧

The Beatson, Glasgow, United Kingdom

and more 6 locations

Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.

First Posted Date
2019-08-12
Last Posted Date
2024-02-05
Lead Sponsor
UNICANCER
Target Recruit Count
172
Registration Number
NCT04053322
Locations
🇫🇷

Centre Henri-Becquerel, Rouen, France

🇫🇷

Institut de Cancerologie de Montpellier, Montpellier, France

Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

First Posted Date
2019-08-02
Last Posted Date
2023-10-13
Lead Sponsor
Academic and Community Cancer Research United
Target Recruit Count
36
Registration Number
NCT04042831
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

and more 3 locations

Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

First Posted Date
2019-07-30
Last Posted Date
2023-11-01
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
100
Registration Number
NCT04038502
Locations
🇺🇸

Boise VA Medical Center, Boise, ID, Boise, Idaho, United States

🇺🇸

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States

🇺🇸

Philadelphia MultiService Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States

and more 15 locations

Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

First Posted Date
2019-06-19
Last Posted Date
2024-07-18
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
58
Registration Number
NCT03991832
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

First Posted Date
2019-06-06
Last Posted Date
2024-11-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
672
Registration Number
NCT03976323
Locations
🇺🇸

Renovatio Clinical ( Site 0062), The Woodlands, Texas, United States

🇦🇺

Liverpool Hospital ( Site 1201), Liverpool, New South Wales, Australia

🇨🇦

Stronach Regional Cancer Centre ( Site 0101), Newmarket, Ontario, Canada

and more 175 locations
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