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

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Phase 3

Active, not recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Alpelisib
Drug: Paclitaxel
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: Olaparib

First Posted Date: 2021-01-28

Last Posted Date: 2024-11-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 358

Registration Number: NCT04729387

Locations: 🇺🇸
Arizona Oncology Associates, Phoenix, Arizona, United States
🇺🇸
Highlands Oncology Group, Fayetteville, Arkansas, United States
🇺🇸
Maryland Oncology Hematology P A, Silver Spring, Maryland, United States

and more 22 locations

Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Phase 1

Recruiting

Conditions: Brain Metastases, Adult
Breast Cancer

Interventions: Drug: Olaparib
Radiation: Stereotactic Radiosurgery
Drug: Durvalumab
Drug: Physicians Choice systemic chemotherapy

First Posted Date: 2021-01-15

Last Posted Date: 2024-11-22

Lead Sponsor: Colette Shen

Target Recruit Count: 41

Registration Number: NCT04711824

Locations: 🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Memorial Healthcare System, Hollywood, Florida, United States

and more 4 locations

A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer

Phase 2

Recruiting

Conditions: TNBC - Triple-Negative Breast Cancer
Breast Cancer
Metastatic Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation
Drug: Olaparib

First Posted Date: 2020-12-24

Last Posted Date: 2024-10-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT04683679

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

A Study of Pembrolizumab and Olaparib for People with Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy

Phase 2

Active, not recruiting

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Homologous Recombination Deficiency (HRD)

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2020-12-14

Last Posted Date: 2024-10-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 63

Registration Number: NCT04666740

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities), Commack, New York, United States

and more 4 locations

WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

Phase 2

Recruiting

Conditions: Epithelial Ovarian Cancer

Interventions: Drug: olaparib
Drug: durvalumab

First Posted Date: 2020-11-25

Last Posted Date: 2024-08-09

Lead Sponsor: AGO Research GmbH

Target Recruit Count: 60

Registration Number: NCT04644289

Locations: 🇩🇪
Universitätsklinikum Mannheim GmbH, Frauenklinik, Mannheim, Baden-Württemberg, Germany
🇩🇪
Mammazentrum HH am Krankenhaus Jerusalem, Gynäkologisches Operationszentrum Hamburg, Hamburg, Germany
🇩🇪
Charité Berlin, Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie, Berlin, Germany

and more 3 locations

Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Olaparib
Drug: Pembrolizumab
Drug: Carboplatin
Procedure: Peripheral blood draw

First Posted Date: 2020-11-25

Last Posted Date: 2024-07-19

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 30

Registration Number: NCT04643379

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

Phase 2

Conditions: Cervical Cancer

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2020-11-24

Last Posted Date: 2022-08-09

Lead Sponsor: Saitama Medical University International Medical Center

Target Recruit Count: 28

Registration Number: NCT04641728

Locations: 🇯🇵
Saitama Medical Uiversity International Medical Center, Hidaka, Saitama, Japan

Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

Phase 1

Recruiting

Conditions: Recurrent Ovarian High Grade Serous Adenocarcinoma
Recurrent Platinum-Resistant Ovarian Carcinoma

Interventions: Drug: Abemaciclib
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Olaparib

First Posted Date: 2020-11-18

Last Posted Date: 2024-12-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT04633239

Locations: 🇺🇸
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 19 locations

Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

Phase 2

Recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: Olaparib
Drug: Pembrolizumab

First Posted Date: 2020-11-18

Last Posted Date: 2022-12-06

Lead Sponsor: California Pacific Medical Center Research Institute

Target Recruit Count: 41

Registration Number: NCT04633902

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States

Study of Pamiparib in Newly Diagnosed and rGBM

Early Phase 1

Recruiting

Conditions: Glioblastoma
Glioblastoma Multiforme
Glioblastoma Multiforme, Adult

Interventions: Drug: Olaparib
Drug: Pamiparib
Radiation: Radiation therapy
Drug: Temozolomide

First Posted Date: 2020-11-04

Last Posted Date: 2024-08-29

Lead Sponsor: Nader Sanai

Target Recruit Count: 30

Registration Number: NCT04614909

Locations: 🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

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