Therapy Detail

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Therapy Name Olaparib + Temozolomide
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 31 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 (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, 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).
Temozolomide Temodar Methazolastone|TMZ Chemotherapy - Alkylating 18 Temodar (temozolomide) is a dacarbazine analog and cytotoxic alkylating agent (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RAD51B del uterus leiomyosarcoma predicted - sensitive Olaparib + Temozolomide Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) and Temodar (temozolomide) combination treatment resulted in stable disease and progression-free survival lasting 980 days in a patient with advanced uterine leiomyosarcoma harboring a homozygous deletion of RAD51B (PMID: 37467452). 37467452

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01858168 Phase I Olaparib + Temozolomide Phase I Study of Olaprib and Temozolomide for Ewings Sarcoma Active, not recruiting USA 0
NCT04394858 Phase II Olaparib + Temozolomide Temozolomide Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer Recruiting USA 0
NCT05432791 Phase II Pazopanib Olaparib + Temozolomide Trabectedin Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working Active, not recruiting USA 1
NCT04166435 Phase II Olaparib + Temozolomide TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer Completed USA 0
NCT06630325 Phase II Fulvestrant Olaparib + Pegylated liposomal doxorubicin Abemaciclib + Letrozole Abemaciclib Olaparib Olaparib + Temozolomide Abemaciclib + Tamoxifen Abemaciclib + Gemcitabine Gefitinib Abemaciclib + Pemetrexed Disodium Abemaciclib + Exemestane Osimertinib Carboplatin + Gefitinib + Pemetrexed Disodium Carboplatin + Olaparib + Paclitaxel A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced, Recurrent Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer Not yet recruiting USA 0
NCT03212742 Phase Ib/II Olaparib + Temozolomide Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients (OLA-TMZ-RTE-01) Active, not recruiting FRA 0
NCT03880019 Phase II Olaparib + Temozolomide Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma Active, not recruiting USA 0
NCT05128734 Phase II Olaparib + Temozolomide Temozolomide Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) Not yet recruiting CAN 0


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