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

Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

Phase 2

Withdrawn

Conditions: Platinum-Refractory Fallopian Tube Carcinoma
Platinum-Refractory Ovarian Carcinoma
Platinum-Refractory Primary Peritoneal Carcinoma
Recurrent Platinum-Resistant Fallopian Tube Carcinoma
Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
Recurrent Fallopian Tube Endometrioid Adenocarcinoma
Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
Recurrent Platinum-Resistant Ovarian Carcinoma
Recurrent Ovarian Endometrioid Adenocarcinoma
Recurrent Ovarian High Grade Serous Adenocarcinoma

Interventions: Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Copanlisib Hydrochloride
Drug: Paclitaxel
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
Drug: Olaparib
Drug: Topotecan Hydrochloride

First Posted Date: 2022-03-25

Last Posted Date: 2023-09-26

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT05295589

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States

and more 2 locations

Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma

Phase 2

Recruiting

Conditions: Pancreatic Acinar Cell Carcinoma

Interventions: Drug: Olaparib

First Posted Date: 2022-03-18

Last Posted Date: 2024-12-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT05286827

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib as Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma

Phase 2

Active, not recruiting

Conditions: Esophagogastric Adenocarcinoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib
Drug: mFOLFOX-6
Drug: CapOX

First Posted Date: 2022-03-07

Last Posted Date: 2024-12-10

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 31

Registration Number: NCT05268510

Locations: 🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Germany

The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation

Phase 2

Conditions: Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Prostate Carcinoma

Interventions: Drug: Olaparib

First Posted Date: 2022-03-02

Last Posted Date: 2022-03-02

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 30

Registration Number: NCT05262608

Locations: 🇨🇳
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

Phase 3

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Olaparib
Drug: Chemotherapy drug

First Posted Date: 2022-02-24

Last Posted Date: 2023-03-24

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 200

Registration Number: NCT05255471

Locations: 🇮🇹
IRCCS Istituto Nazionale Tumori di Napoli, Naples, Italy

Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

Phase 2

Recruiting

Conditions: Endometrial Cancer

Interventions: Drug: Olaparib
Other: Observation
Radiation: Pelvic external beam radiotherapy
Drug: Durvalumab
Drug: Medroxyprogesterone Acetate
Radiation: Vaginal brachytherapy
Drug: Chemotherapy
Drug: Megestrol Acetate

First Posted Date: 2022-02-24

Last Posted Date: 2024-11-28

Lead Sponsor: Leiden University Medical Center

Target Recruit Count: 1615

Registration Number: NCT05255653

Locations: 🇨🇦
The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada
🇳🇱
Medisch Spectrum Twente, Enschede, Netherlands
🇳🇱
The MMRd-GREEN trial: Leiden University Medical Center, Leiden, Netherlands

and more 11 locations

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Cancer of Ovary
Prostatic Cancer
Castration Resistant Prostatic Neoplasms
Breast Tumor
Cancer of the Ovary
Prostate Cancer
Cancer of the Prostate
Triple-negative Breast Cancer
Cancer of Breast
Ovary Cancer

Interventions: Drug: NUV-868
Drug: Enzalutamide
Drug: Olaparib

First Posted Date: 2022-02-23

Last Posted Date: 2024-10-02

Lead Sponsor: Nuvation Bio Inc.

Target Recruit Count: 657

Registration Number: NCT05252390

Locations: 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
St. Vincent-Frontier Cancer Center, Billings, Montana, United States
🇺🇸
Morristown Medical Center, Morristown, New Jersey, United States

and more 27 locations

A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: RO7623066
Drug: Olaparib
Drug: Carboplatin

First Posted Date: 2022-02-15

Last Posted Date: 2024-07-05

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 250

Registration Number: NCT05240898

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Mary Crowley Medical Research Center, Dallas, Texas, United States

and more 11 locations

SMMART Adaptive Clinical Treatment (ACT) Trial

Early Phase 1

Withdrawn

Conditions: Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Prostate Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Breast Carcinoma
Stage IV Ovarian Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma

First Posted Date: 2022-02-14

Last Posted Date: 2024-01-23

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT05238831

Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy

Phase 2

Recruiting

Conditions: DNA Damage Repair Deficiency
Biliary Tract Cancer

Interventions: Drug: Olaparib
Drug: Durvalumab

First Posted Date: 2022-02-03

Last Posted Date: 2024-01-17

Lead Sponsor: Asan Medical Center

Target Recruit Count: 62

Registration Number: NCT05222971

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

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