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

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2

Recruiting

Conditions: Metastatic HER2-Negative Breast Carcinoma
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Ovarian Carcinoma
Unresectable HER2-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
Advanced Malignant Solid Neoplasm

First Posted Date: 2022-10-03

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2900

Registration Number: NCT05564377

Locations: 🇺🇸
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
🇺🇸
Corewell Health Dearborn Hospital, Dearborn, Michigan, United States
🇺🇸
Corewell Health Farmington Hills Hospital, Farmington Hills, Michigan, United States

and more 422 locations

Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial

Phase 2

Recruiting

Conditions: Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Drug: Olaparib
Drug: Selumetinib Sulfate

First Posted Date: 2022-09-26

Last Posted Date: 2024-12-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 165

Registration Number: NCT05554328

Locations: 🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States

and more 252 locations

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Phase 2

Not yet recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Olaparib
Drug: Fulvestrant

First Posted Date: 2022-09-10

Last Posted Date: 2022-09-15

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 64

Registration Number: NCT05536128

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma

Phase 2

Recruiting

Conditions: Uveal Melanoma
Ocular Melanoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2022-09-01

Last Posted Date: 2024-12-06

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 37

Registration Number: NCT05524935

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

Phase 2

Not yet recruiting

Conditions: Solid Tumor

Interventions: Drug: Olaparib

First Posted Date: 2022-08-31

Last Posted Date: 2022-08-31

Lead Sponsor: Hebei Medical University Fourth Hospital

Target Recruit Count: 30

Registration Number: NCT05522491

Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Prostate Cancer
Castration-resistant Prostate Cancer

Interventions: Drug: Olaparib
Dietary Supplement: Vitamin C

First Posted Date: 2022-08-15

Last Posted Date: 2024-12-04

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 15

Registration Number: NCT05501548

Locations: 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations

Phase 2

Recruiting

Conditions: Prostate Cancer
High-Risk Cancer
BRCA1 Mutation
BRCA2 Mutation
Prostatic Adenocarcinoma

Interventions: Drug: Olaparib
Drug: LHRH agonist

First Posted Date: 2022-08-12

Last Posted Date: 2024-10-24

Lead Sponsor: Rana McKay, MD

Target Recruit Count: 32

Registration Number: NCT05498272

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 2 locations

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Triple Negative Breast Neoplasms
Triple Negative Breast Cancer
Breast Neoplasms
Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
BRCA Mutation
BRCA-Associated Breast Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Olaparib
Procedure: Definitive Surgery

First Posted Date: 2022-08-03

Last Posted Date: 2024-02-13

Lead Sponsor: Okayama University

Target Recruit Count: 23

Registration Number: NCT05485766

Locations: 🇯🇵
St. Luke's International Hospital, Tokyo, Japan
🇯🇵
Aichi Cancer Center, Nagoya, Japan
🇯🇵
Okayama University Hospital, Okayama, Japan

Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2

Phase 2

Withdrawn

Conditions: Recurrent Metastatic Melanoma
Cutaneous Melanoma
Mucosal Melanoma
Uveal Melanoma

Interventions: Drug: Olaparib

First Posted Date: 2022-08-01

Last Posted Date: 2024-01-19

Lead Sponsor: Dana-Farber Cancer Institute

Registration Number: NCT05482074

Surgical Pembro +/- Olaparib w TMZ for rGBM

Phase 2

Recruiting

Conditions: Recurrent Glioblastoma
Glioblastoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib
Drug: Temozolomide

First Posted Date: 2022-07-19

Last Posted Date: 2024-01-29

Lead Sponsor: L. Nicolas Gonzalez Castro, MD, PhD

Target Recruit Count: 78

Registration Number: NCT05463848

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Drug Development Updates

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