Olaparib

Generic Name: Olaparib

Brand Names: Lynparza

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₃FN_₄O_₃

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.
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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.
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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

Clinical Trials

Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Phase 1

Completed

Conditions: Primary Peritoneal Cancer
Ovarian Cancer
Fallopian Tube Cancer

Interventions: Drug: Paclitaxel,
Drug: Bevacizumab
Drug: Cisplatin
Drug: Olaparib

First Posted Date: 2014-04-24

Last Posted Date: 2020-08-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 17

Registration Number: NCT02121990

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 2 locations

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer Metastatic

Interventions: Drug: AZD2014
Drug: Standard maintenance for squamous NSCLC
Drug: Durvalumab
Drug: AZD4547
Drug: Pemetrexed
Drug: AZD5363
Drug: AZD8931
Drug: Selumetinib
Drug: Vandetanib
Drug: savolitinib
Drug: Olaparib

First Posted Date: 2014-04-17

Last Posted Date: 2024-01-10

Lead Sponsor: UNICANCER

Target Recruit Count: 999

Registration Number: NCT02117167

Locations: 🇫🇷
Hôpital Avicenne, Bobigny, France
🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Institut Paoli Calmettes, Marseille, France

and more 34 locations

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Phase 1

Completed

Conditions: Solid Tumours

Interventions: Drug: Olaparib
Drug: Letrozole
Drug: Tamoxifen
Drug: Anastrozole
Procedure: Pharmacokinetic sampling

First Posted Date: 2014-03-21

Last Posted Date: 2019-10-02

Lead Sponsor: AstraZeneca

Target Recruit Count: 79

Registration Number: NCT02093351

Locations: 🇬🇧
Research Site, Sutton, United Kingdom

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Placebo
Drug: Olaparib

First Posted Date: 2014-01-10

Last Posted Date: 2024-08-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 1837

Registration Number: NCT02032823

Locations: 🇬🇧
Research Site, Sutton, United Kingdom

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Phase 3

Active, not recruiting

Conditions: Breast Cancer Metastatic
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation

Interventions: Drug: Olaparib
Drug: Physician's choice chemotherapy

First Posted Date: 2013-12-04

Last Posted Date: 2024-10-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 302

Registration Number: NCT02000622

Locations: 🇬🇧
Research Site, Plymouth, United Kingdom

Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.

Phase 2

Completed

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: Olaparib
Drug: Placebo
Drug: Abiraterone
Drug: Prednisone or prednisolone

First Posted Date: 2013-10-30

Last Posted Date: 2023-11-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 158

Registration Number: NCT01972217

Locations: 🇬🇧
Research Site, Westcliff-on-Sea, United Kingdom

Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Olaparib
Drug: Placebo
Drug: Paclitaxel

First Posted Date: 2013-08-16

Last Posted Date: 2024-03-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 525

Registration Number: NCT01924533

Locations: 🇨🇳
Research Site, Taoyuan, Taiwan

Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma

Phase 1

Active, not recruiting

Conditions: Ewing Sarcoma
Rhabdomyosarcoma

Interventions: Drug: Olaparib
Drug: Temozolomide
Drug: Irinotecan

First Posted Date: 2013-05-21

Last Posted Date: 2024-03-12

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 93

Registration Number: NCT01858168

Locations: 🇺🇸
St. Jude's Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations