Therapy Detail

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Therapy Name Ceralasertib + Olaparib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ceralasertib AZD6738|AZD-6738 ATR Inhibitor 14 Ceralasertib (AZD6738) is an inhibitor of ATR, which may enhance the sensitivity of chemotherapeutic agents, potentially resulting in tumor regression (PMID: 26517239, PMID: 31836456).
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 26 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
IDH2 R172S chondrosarcoma sensitive Ceralasertib + Olaparib Preclinical - Cell culture Actionable In a preclinical study, the combination of Lynparza (olaparib) and Ceralasertib (AZD6738) resulted in a greater decrease in cell viability compared to Ceralasertib (AZD6738) alone in chondrosarcoma cells harboring IDH2 R172S in culture (PMID: 34027408). 34027408
ATM inact mut Advanced Solid Tumor predicted - sensitive Ceralasertib + Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Ceralasertib (AZD6738) and Lynparza (olaparib) combination treatment resulted in an overall response rate of 20% (1/5) and a clinical benefit rate of 40% (2/5) in patients with advanced solid tumors harboring ATM inactivating mutations, including a durable complete response in a patient with breast cancer and a durable stable disease in a patient with adenoid cystic carcinoma of minor salivary gland (PMID: 34527850; NCT02576444). 34527850
ATM loss head and neck cancer predicted - sensitive Ceralasertib + Olaparib Preclinical - Cell culture Actionable In a preclinical study, the combination of AZD6738 and Lynparza (olaparib) resulted in a synergistic effect, demonstrating cell death in head and neck cancer cells harboring ATM loss in culture (Mol Cancer Ther 2015;14(12 Suppl 2):Abstract nr C60). detail...
ATM LOH ATM inact mut estrogen-receptor positive breast cancer predicted - sensitive Ceralasertib + Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Ceralasertib (AZD6738) and Lynparza (olaparib) combination treatment resulted in an ongoing complete response for over 26 months in a patient with estrogen receptor–positive metastatic breast cancer harboring germline ATM mutation with accompanying loss of heterozygosity (LOH) (PMID: 34527850; NCT02576444). 34527850
IDH1 R132S cholangiocarcinoma sensitive Ceralasertib + Olaparib Preclinical - Cell culture Actionable In a preclinical study, the combination of Lynparza (olaparib) and Ceralasertib (AZD6738) resulted in a greater decrease in cell viability compared to Ceralasertib (AZD6738) alone in cholangiocarcinoma cells harboring IDH1 R132S in culture (PMID: 34027408). 34027408
ATM P1069fs ATM LOH salivary gland adenoid cystic carcinoma predicted - sensitive Ceralasertib + Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Ceralasertib (AZD6738) and Lynparza (olaparib) combination treatment resulted in an ongoing 22% reduction in target lesions in a patient with adenoid cystic carcinoma of minor salivary gland harboring germline ATM P1069fs with accompanying loss of heterozygosity (LOH), who remained on treatment for over 26 months (PMID: 34527850; NCT02576444). 34527850
IDH1 R132C fibrosarcoma sensitive Ceralasertib + Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Lynparza (olaparib) and Ceralasertib (AZD6738) resulted in a greater delay in tumor growth compared to Ceralasertib (AZD6738) alone in fibrosarcoma cell line xenograft models harboring IDH1 R132C (PMID: 34027408). 34027408
IDH1 R132H Advanced Solid Tumor sensitive Ceralasertib + Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Lynparza (olaparib) and Ceralasertib (AZD6738) resulted in a greater decrease in cell survival compared to Ceralasterib (AZD6738) alone in cells expressing IDH1 R132H in culture, and a longer delay in tumor growth in cell line xenograft models (PMID: 34027408). 34027408

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03682289 Phase II Ceralasertib + Olaparib Olaparib Phase II Trial of AZD6738 Alone and in Combination With Olaparib Recruiting USA 0
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib OLAParib COmbinations (OLAPCO) Active, not recruiting USA 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
NCT04065269 Phase II Ceralasertib + Olaparib Ceralasertib ATr Inhibitor in Combination With Olaparib in Gynaecological Cancers With ARId1A Loss or no Loss (ATARI) Recruiting 1
NCT02264678 Phase Ib/II Ceralasertib Carboplatin + Ceralasertib Ceralasertib + Durvalumab Ceralasertib + Olaparib Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents Recruiting USA | FRA 2
NCT03787680 Phase II Ceralasertib + Olaparib Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial) Active, not recruiting USA 0
NCT03182634 Phase II Fulvestrant Ceralasertib + Olaparib Capivasertib Fulvestrant + Neratinib The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial (plasmaMATCH) Recruiting 1
NCT03462342 Phase II Ceralasertib + Olaparib Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer (CAPRI) Recruiting USA 0
NCT04417062 Phase II Ceralasertib + Olaparib Olaparib With Ceralasertib in Recurrent Osteosarcoma Recruiting USA 0
NCT03878095 Phase II Ceralasertib + Olaparib Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors Recruiting USA 0
NCT04090567 Phase II Cediranib + Olaparib Ceralasertib + Olaparib Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer Recruiting 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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