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

Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

First Posted Date
2016-09-14
Last Posted Date
2023-10-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
9
Registration Number
NCT02899728
Locations
🇺🇸

Los Angeles County-USC Medical Center, Los Angeles, California, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

and more 21 locations

Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer

First Posted Date
2016-09-09
Last Posted Date
2024-08-22
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
90
Registration Number
NCT02893917
Locations
🇺🇸

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

and more 13 locations

Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.

First Posted Date
2016-08-29
Last Posted Date
2020-02-07
Lead Sponsor
Hellenic Cooperative Oncology Group
Target Recruit Count
41
Registration Number
NCT02882308
Locations
🇬🇷

Euromedica General Clinic of Thessaloniki, Thessaloníki, Thessaloniki, Greece

🇬🇷

University Hospital "Attikon", 2nd Department of Internal Medicine, Division of Oncology, Athens, Greece

Multi-maintenance Olaparib After Disease Recurrence in Participants With Platinum Sensitive BRCAm High Grade Serous Ovarian Cancer

First Posted Date
2016-08-04
Last Posted Date
2022-02-22
Lead Sponsor
The Christie NHS Foundation Trust
Target Recruit Count
28
Registration Number
NCT02855697
Locations
🇬🇧

The Christie NHS Foundation Trust, Manchester, United Kingdom

Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

First Posted Date
2016-07-29
Last Posted Date
2024-08-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
81
Registration Number
NCT02849496
Locations
🇺🇸

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

🇺🇸

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

and more 55 locations

A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

First Posted Date
2016-06-01
Last Posted Date
2023-03-03
Lead Sponsor
Institut Bergonié
Target Recruit Count
41
Registration Number
NCT02787642
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Bérard, Lyon, France

🇫🇷

Institut du Cancer de Montpellier, Montpellier, France

and more 1 locations

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

First Posted Date
2016-05-12
Last Posted Date
2024-11-25
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
136
Registration Number
NCT02769962
Locations
🇺🇸

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

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