Therapy Detail

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Therapy Name Olaparib
Synonyms
Therapy Description

Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, germline BRCA-mutated and ERBB2 (HER2)-negative breast cancer, and advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 25 Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 R132C sarcoma sensitive Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, Lynparza (olaparib) treatment delayed tumor growth in cell line xenograft models of sarcoma harboring IDH1 R132C (PMID: 28148839). 28148839
TP53 mutant ovarian cancer predicted - sensitive Olaparib Preclinical - Pdx Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited tumor growth but did not induce regression in a patient-derived xenograft (PDX) model of ovarian cancer harboring wild-type ATM and TP53 mutation (PMID: 31699977). 31699977
ATM del lung non-small cell carcinoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of ATM knockout non-small cell lung carcinoma cells in culture (PMID: 31699977). 31699977
ATM V1841I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm V1841I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 mutant acute myeloid leukemia predicted - sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH1 mutation were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
IDH1 R132H colon carcinoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, colon carcinoma cells over expressing IDH1 R132H demonstrated increased sensitivity to Lynparza (olaparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
ATM H2038Y neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm H2038Y, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM inact mut chronic lymphocytic leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived chronic lymphocytic leukemia cells with inactivating mutations in ATM, that had been induced to proliferate in culture, demonstrated increased sensitivity to growth inhibition by Lynparza (olaparib) compared to ATM wild-type cells (PMID: 20739657). 20739657
ATM L1956H neuroblastoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm L1956H, resulted in similar cell viability levels as cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 R132H Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Lynparza (olaparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
ATM R2691C neuroblastoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of transformed neuroblastoma cells expressing ATM R2691C resulted in similar cell viability levels to wild-type Atm in culture (PMID: 29059438). 29059438
PTEN negative endometrial carcinoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment did not significantly increase DNA damage or inhibit growth of PTEN-deficient endometrial carcinoma cell lines in culture (PMID: 28945226). 28945226
ATM S1455R neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm S1455R, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 R132H colorectal cancer predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, colorectal cancer cells harboring IDH1 R132H were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
ATM S1905Ifs*25 gallbladder carcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, treatment with Lynparza (olaparib) resulted in improved clinical symptoms and progression-free survival of 13 months in a patient with gallbladder carcinoma harboring ATM S1905Ifs*25 (PMID: 32045060). 32045060
ATM P604S neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm P604S, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 R132S chondrosarcoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in stable disease lasting 10 months in a patient with chondrosarcoma harboring IDH1 R132S (PMID: 34994649, NCT02576444). 34994649
ATM L1874F neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm L1874F, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM inact mut mantle cell lymphoma sensitive Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, a mantle cell lymphoma cell line with ATM inactivation demonstrated sensitivity to Lynparza (olaparib) in culture and in xenograft models (PMID: 20739657). 20739657
ATM P960H neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm P960H, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 R132H high grade glioma predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of a glioma cell line expressing IDH1 R132H in culture (PMID: 34118569). 34118569
IDH1 R132H high grade glioma predicted - sensitive Olaparib Phase II Actionable In a Phase II trial (OLAGLI), Lynparza (olaparib) therapy was well tolerated in high grade glioma patients harboring IDH1 R132 (32/35) or other IDH mutations (3/35), and led to a partial response in 5% (2/35) and stable disease in 37% (14/35) of 35 evaluable patients, median progression-free survival (PFS) of 2.3 mo, median overall survival of 15.9 mo, a median duration of response of 9 mo, and a 6-mo PFS of 31% (11/35) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2007-2007; NCT03561870). detail...
ATM mutant breast cancer no benefit Olaparib Case Reports/Case Series Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment did not result in an objective response in 4 patients with metastatic breast cancer harboring only germline mutations in ATM (PMID: 33119476; NCT03344965). 33119476
ATM A59S neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm A59S, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM mutant Advanced Solid Tumor predicted - sensitive Olaparib Phase II Actionable In a Phase II trial (TAPUR), Lynparza (olaparib) treatment resulted in an objective response rate of 8% and a disease control rate of 25% (9/36, 1 complete response, 2 partial responses, 6 stable disease at 16+ weeks) in patients with advanced solid tumors harboring ATM mutations (Cancer Res 2022;82(12_Suppl):Abstract nr CT110; NCT02693535). detail...
ATM L1449* prostate adenocarcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in stable disease for more than 6 months in a patient with prostate adenocarcinoma harboring ATM L1449*, amplification of AR, MYC, BCL9, MCL1, MDM4, RPS6KB1, APEX1, PNP, ATP11B, and DCUN1D1, and a TMPRSS2-ERG fusion (PMID: 29304353). 29304353
IDH1 R132C chondrosarcoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in a partial response with 59% tumor reduction lasting 14 months in one patient and stable disease lasting 7.5 months in one patient out of four patients with chondrosarcoma harboring IDH1 R132C (PMID: 34994649, NCT02576444). 34994649
ATM mutant prostate cancer sensitive Olaparib Phase II Actionable In a Phase II clinical trial, 80% (4/5) of metastatic castration-resistant prostate cancer patients with ATM truncation mutations demonstrated response to Lynparza (olaparib) treatment (Cancer Res August 1, 2015 75:CT322). detail...
ATM del head and neck cancer sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment induced genomic instability, cell cycle arrest, and inhibited viability of an ATM knockout head and neck cancer cell line in culture (PMID: 31699977). 31699977
ATM V519I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm V519I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM S824F neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm S824F, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
PTEN del endometrial carcinoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment did not significantly increase DNA damage or inhibit growth of an endometrial carcinoma cell line with PTEN knocked out via CRISPR/Cas9 system in culture (PMID: 28945226). 28945226
IDH2 mutant acute myeloid leukemia predicted - sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH2 mutation were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
ATM K2749I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm K2749I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM inact mut lymphoid leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, lymphoblastoid cell lines with ATM inactivation derived from ataxia-telangiectasia patients demonstrated increased sensitivity to Lynparza (olaparib) in culture, compared to ATM wild-type cell lines (PMID: 20739657). 20739657
IDH2 V305M malignant epithelioid hemangioendothelioma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in stable disease lasting 11 months in a patient with pulmonary epithelioid hemangioendothelioma harboring IDH2 V305M (PMID: 34994649, NCT02576444). 34994649
ATM T1200Lfs*7 NRAS Q61K TP53 R213* sarcoma predicted - resistant Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in rapid disease progression in a patient with high-grade sarcoma harboring ATM T1200Lfs*7, NRAS Q61K, and TP53 R213* (PMID: 29304353). 29304353
ATM del prostate cancer no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, ATM-deficient prostate cancer cell lines did not respond to treatment with Lynparza (olaparib) in culture (PMID: 32127357). 32127357
ATM inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment improved progression-free survival (7.4 vs 3.6 mo, HR=0.34, p<0.001), objective response rate (33%, 28/84 vs 2%, 1/43, OR=20.86, p<0.001), and median time to pain progression (HR=0.44, p=0.02) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in BRCA1/2 or ATM who progressed on hormone therapy (PMID: 32343890; NCT02987543). detail... 32343890 detail...
ATM inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 36.8% (7/19) and a RECIST objective response rate of 8.3% (1/12) in patients with castration-resistant prostate cancer harboring deleterious ATM mutations (PMID: 31806540; NCT01682772). 31806540
ATM inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II clinical trial, 80% (4/5) of metastatic, castration-resistant prostate cancer patients harboring an ATM inactivating mutation responded to Lynparza (olaparib) (PMID: 26510020). 26510020
ATM inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in ATM (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03737643 Phase III Bevacizumab + Carboplatin + Paclitaxel Bevacizumab + Carboplatin + Durvalumab + Paclitaxel Bevacizumab + Durvalumab + Olaparib Olaparib Bevacizumab + Durvalumab Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients. (DUO-O) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT03402841 Phase III Olaparib Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION) Completed ITA | ESP | CAN | BEL | AUT 13
NCT03233204 Phase II Olaparib Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Active, not recruiting USA 1
NCT02561832 Phase I Cyclophosphamide Olaparib Carboplatin A Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin in Patients With HER-2 Negative Breast Cancer Terminated USA | ESP 0
NCT03263650 Phase II Cabazitaxel + Carboplatin Olaparib Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC Active, not recruiting USA 0
NCT03682289 Phase II Ceralasertib + Olaparib Olaparib Phase II Trial of AZD6738 Alone and in Combination With Olaparib Recruiting USA 0
NCT02476968 FDA approved Olaparib To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA) Completed ITA | ESP | CAN 5
NCT03344965 Phase II Olaparib Olaparib In Metastatic Breast Cancer Recruiting USA 0
NCT01445418 Phase I Olaparib Carboplatin AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer Completed USA 0
NCT03448718 Phase II Olaparib Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Active, not recruiting USA 0
NCT02029001 Phase II Durvalumab + Tremelimumab Olaparib Pazopanib Nilotinib Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: My Own Specific Treatment (MOST plus) Recruiting FRA 0
NCT01844986 Phase III Olaparib Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1) Active, not recruiting USA | ITA | FRA | ESP | CAN 10
NCT04042831 Phase II Olaparib Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations Recruiting USA 0
NCT03375307 Phase II Olaparib Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer With DNA-Repair Genetic Changes Recruiting USA 0
NCT04041128 Phase I Olaparib PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer Active, not recruiting USA 0
NCT01874353 Phase III Olaparib Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 10
NCT02677038 Phase II Olaparib Olaparib in Treating Patients With Stage IV Pancreatic Cancer Completed USA 0
NCT03317392 Phase Ib/II Olaparib Olaparib and Radium Ra 223 Dichloride in Treating Men With Metastatic Castration-Resistant Prostate Cancer That Has Spread to the Bone Recruiting USA 0
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib OLAParib COmbinations (OLAPCO) Active, not recruiting USA 0
NCT03212274 Phase II Olaparib Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Recruiting USA 0
NCT02446600 Phase III Cediranib + Olaparib Olaparib Carboplatin + Gemcitabine + Paclitaxel + Pegylated liposomal-doxorubicin Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting USA | CAN 2
NCT03367689 Phase II Olaparib A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent (NOBROLA) Terminated ESP 0
NCT05501548 Phase II Olaparib Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer Not yet recruiting USA 0
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Not yet recruiting DEU 0
NCT02849496 Phase II Olaparib Atezolizumab + Olaparib Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer Active, not recruiting USA 0
NCT03967938 Phase II Olaparib Efficacy of Olaparib in Advanced Cancers Occurring in Patients With Germline Mutations or Somatic Tumor Mutations in Homologous Recombination Genes (1-2018 BSMO) Recruiting BEL 0
NCT03953898 Phase II Olaparib Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation Recruiting USA 0
NCT02987543 Phase III Olaparib Enzalutamide Abiraterone Study of Olaparib (Lynparza) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | AUT 13
NCT02502266 Phase II Topotecan Paclitaxel Doxorubicin Olaparib Cediranib Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting USA | CAN 3
NCT02485990 Phase Ib/II Olaparib Tremelimumab Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma) Terminated USA 0
NCT02787642 Phase I Olaparib A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma (RADIOSARP) Recruiting FRA 0
NCT04239014 Phase II Olaparib Ceralasertib + Olaparib A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. (DUETTE) Withdrawn USA | ITA | ESP | CAN 0
NCT03745950 Phase II Olaparib UTOLA: UTerin OLAparib (UTOLA) Active, not recruiting FRA 0
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting USA 0
NCT03079687 Expanded access Olaparib Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer. Approved for marketing USA 0
NCT03022409 Phase I Olaparib Ceralasertib A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Completed USA | FRA 1
NCT04377087 Phase II Olaparib Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer Active, not recruiting USA 0
NCT03167619 Phase II Durvalumab + Olaparib Olaparib Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (DORA) Completed USA 0
NCT04038502 Phase II Olaparib Carboplatin Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA) Recruiting USA 0
NCT04236414 Phase I Olaparib Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours Recruiting USA | ITA | FRA | ESP | DEU | CAN 9
NCT02032823 Phase III Olaparib Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 16
NCT05286827 Phase II Olaparib Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma Recruiting USA 0
NCT03741426 Phase II Durvalumab Cediranib Durvalumab + Olaparib Cediranib + Olaparib Olaparib WIRE - Novel Treatments in Renal Cell Cancer (WIRE) Recruiting 1
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) Recruiting USA 0
NCT03286842 Phase III Olaparib To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients. Completed USA | ITA | FRA | ESP | DEU | CAN 9
NCT03943173 Phase I Olaparib Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery Recruiting USA 0
NCT02489006 Phase II Olaparib A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Active, not recruiting ESP | CAN 2
NCT03579316 Phase II Olaparib Adavosertib + Olaparib Adavosertib With or Without Olaparib in Treating Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Recruiting USA 0
NCT04005690 Phase II Olaparib Cobimetinib Cobimetinib or Olaparib in Treating Patients With Resectable Pancreatic Cancer Recruiting USA 0
NCT02511795 Phase I Adavosertib Olaparib AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors Completed USA | CAN 0
NCT04644289 Phase II Olaparib Durvalumab + Olaparib WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC (WoO) Recruiting DEU 0
NCT04515836 Phase II Olaparib Olaparib in Patients With HRD Malignant Mesothelioma Recruiting USA 0
NCT02446704 Phase Ib/II Olaparib Temozolomide Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy Active, not recruiting USA 0
NCT04548752 Phase II Olaparib + Pembrolizumab Olaparib Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations Recruiting USA 0
NCT02000622 Phase III Olaparib Vinorelbine Eribulin Capecitabine 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. (OlympiAD) Active, not recruiting USA | ITA | FRA | ESP 15
NCT03106987 Phase III Olaparib A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. (OReO) Completed ITA | FRA | ESP | DEU | CAN | BEL 5
NCT02392676 Phase III Olaparib Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations Withdrawn USA 4
NCT04421963 Phase III Olaparib Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (ROSY-O) Enrolling by invitation USA | ITA | FRA | ESP | DEU | CAN | BEL 15
NCT03660826 Phase II Olaparib Cediranib + Olaparib Olaparib and Cediranib Maleate in Treating Patients With Recurrent, Refractory, or Metastatic Endometrial Cancer Recruiting USA 0
NCT05340413 Phase II Olaparib Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) Recruiting ESP 0
NCT03012321 Phase II Abiraterone + Olaparib + Prednisone Abiraterone + Prednisone Olaparib Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects Recruiting USA 0
NCT01972217 Phase II Prednisone Abiraterone Olaparib Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer Active, not recruiting USA | ITA | FRA | ESP | CAN | BEL 5
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Not yet recruiting USA 0
NCT02282020 Phase III Topotecan Paclitaxel Pegylated liposomal-doxorubicin Gemcitabine Olaparib Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3) Completed USA | ITA | ESP | CAN | BEL 8
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) Recruiting CAN 0
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting USA 1
NCT01116648 Phase Ib/II Olaparib Cediranib + Olaparib Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer Active, not recruiting USA 0
NCT02893917 Phase II Cediranib + Olaparib Olaparib Olaparib With or Without Cediranib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Active, not recruiting USA 0
NCT04034927 Phase II Olaparib Olaparib + Tremelimumab Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer Active, not recruiting USA 0
NCT05233982 Phase II Olaparib MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer (MITO 35a) Recruiting ITA 0
NCT03498521 Phase II Atezolizumab + Paclitaxel Carboplatin Carboplatin + Paclitaxel Olaparib Vismodegib Alectinib Bevacizumab + Erlotinib Cisplatin + Gemcitabine Cobimetinib + Vemurafenib Ipatasertib + Paclitaxel Cisplatin + Paclitaxel Gemcitabine Atezolizumab Entrectinib Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Ipatasertib Carboplatin + Gemcitabine A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (CUPISCO) Recruiting ITA | FRA | ESP | DEU | AUT 30
NCT02184195 Phase III Olaparib Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 5
NCT04858334 Phase II Olaparib APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation Recruiting USA 0
NCT04550104 Phase I AZD1390 Olaparib A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC (CONCORDE) Recruiting 1
NCT03742895 Phase II Olaparib Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) Recruiting USA | ITA | FRA | ESP | CAN 16
NCT03740893 Phase II Olaparib Ceralasertib Durvalumab PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer (PHOENIX) Recruiting 1
NCT03598257 Phase II Olaparib Radiation Therapy With or Without Olaparib in Treating Participants With Inflammatory Breast Cancer Recruiting USA | CAN 1
NCT05482074 Phase II Olaparib Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Not yet recruiting USA 0
NCT04456699 Phase III Bevacizumab + Olaparib Bevacizumab + Fluorouracil Olaparib Efficacy and Safety of Olaparib, Olaparib + Bevacizumab Compared to Bevacizumab + 5-Fluorouracil (FU) Active, not recruiting USA | FRA | ESP | DEU | CAN | BEL 12
NCT03432897 Phase II Olaparib BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes (337) Terminated USA 0
NCT03532880 Phase I Olaparib A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer Active, not recruiting USA 0
NCT02588105 Phase I Olaparib AZD0156 Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer Completed USA | ESP 2
NCT04091204 Phase II Olaparib Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study (MITO 31) Recruiting ITA 0
NCT05255653 Phase II Olaparib Medroxyprogesterone Carboplatin Megestrol acetate Paclitaxel Cisplatin Durvalumab Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) Recruiting FRA | CAN 2
NCT03259503 Phase Ib/II Busulfan Olaparib Vorinostat Palifermin Gemcitabine Melphalan Dexamethasone Pyridoxine Rituximab Olaparib Combined With High-Dose Chemotherapy for Refractory Lymphomas Recruiting USA 0
NCT03278717 Phase III Olaparib Cediranib + Olaparib Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients (ICON9) Recruiting CAN 3
NCT04951492 Phase II Olaparib Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma Recruiting USA 0
NCT03955640 Phase I Olaparib Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences Active, not recruiting USA 0
NCT05498155 Phase II Olaparib Durvalumab + Olaparib Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (OlympiaN) Not yet recruiting ITA | FRA | ESP | DEU | BEL | AUT 1
NCT04348045 Phase II Durvalumab + Selumetinib Fluorouracil + Irinotecan + Leucovorin Olaparib Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients (D19-02) Recruiting FRA 0
NCT02983799 Phase II Olaparib Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status Completed USA | CAN 0
NCT05255471 Phase III Carboplatin + Paclitaxel Olaparib Carboplatin + Pegylated liposomal-doxorubicin Carboplatin + Gemcitabine MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. (MITO 35B) Recruiting ITA 0
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting USA 0
NCT04614909 Phase I Olaparib Pamiparib Pamiparib + Temozolomide Olaparib + Pamiparib + Temozolomide Phase 0/2 Study of Pamiparib in Newly Diagnosed and rGBM Recruiting USA 0
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Recruiting USA 0
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Terminated USA 0
NCT03531840 Phase II Olaparib Olaparib in People With Malignant Mesothelioma Completed USA 0
NCT03330847 Phase II Adavosertib + Olaparib Olaparib Ceralasertib + Olaparib To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 8


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