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

Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin

First Posted Date
2017-05-19
Last Posted Date
2023-01-27
Lead Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Target Recruit Count
32
Registration Number
NCT03161132
Locations
🇪🇸

Corporación Sanitaria Parc Taulí, Sabadell, Barcelona, Spain

🇪🇸

Hospital Universitario de Gran Canaria Doctor Negrín, Palmas de Gran Canaria, Gran Canaria, Spain

🇪🇸

Hospital Son Llatzer, Palma De Mallorca, Mallorca, Spain

and more 5 locations

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

First Posted Date
2017-05-16
Last Posted Date
2024-12-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
2316
Registration Number
NCT03155620
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

East Carolina University, Greenville, North Carolina, United States

🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

and more 169 locations

Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2017-05-12
Last Posted Date
2022-11-14
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
780
Registration Number
NCT03150576
Locations
🇬🇧

The Christie, Manchester, Lancs, United Kingdom

🇬🇧

University Hospital Ayr, Ayr, United Kingdom

🇬🇧

Bedford General Hospital, Bedford, United Kingdom

and more 26 locations

Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

First Posted Date
2017-04-25
Last Posted Date
2024-05-08
Lead Sponsor
National Center for Tumor Diseases, Heidelberg
Target Recruit Count
102
Registration Number
NCT03127215
Locations
🇩🇪

Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, Germany

🇩🇪

Universitätsklinikum Frankfurt, Frankfurt, Germany

🇩🇪

Medizinische Fakultät der TU Dresden, Dresden, Germany

and more 6 locations

Olaparib +/- Cediranib or Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

First Posted Date
2017-04-18
Last Posted Date
2024-01-23
Lead Sponsor
University of Oxford
Target Recruit Count
139
Registration Number
NCT03117933
Locations
🇬🇧

Royal Marsden Chelsea & Sutton, London, United Kingdom

🇬🇧

The Christie, Manchester, United Kingdom

🇬🇧

Royal Surrey County Hospital, Guildford, Surrey, United Kingdom

and more 11 locations

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

First Posted Date
2017-04-12
Last Posted Date
2024-01-31
Lead Sponsor
Institut Curie
Target Recruit Count
24
Registration Number
NCT03109080
Locations
🇫🇷

Institut Curie, Paris, France

A Dye for the Detection of Cancer of the Tongue and Mouth

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2017-03-21
Last Posted Date
2024-03-04
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
39
Registration Number
NCT03085147
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Suffolk-Commack (Consent only), Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States

and more 4 locations

Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan

First Posted Date
2017-02-24
Last Posted Date
2018-05-17
Lead Sponsor
AstraZeneca
Registration Number
NCT03063710
Locations
🇯🇵

Research Site, Chuo-ku, Tokyo, Japan

Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-02-17
Last Posted Date
2021-09-02
Lead Sponsor
Geoffrey Shapiro, MD, PhD
Target Recruit Count
29
Registration Number
NCT03057145
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-02-08
Last Posted Date
2024-07-03
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
51
Registration Number
NCT03047135
Locations
🇺🇸

Allegheny Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

and more 1 locations
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