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|Therapy Name||Everolimus + Hydroxychloroquine|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Everolimus||Afinitor||RAD001|Zortress||mTORC1 Inhibitor 8||Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).|
|Hydroxychloroquine||Plaquenil||HCQ||Plaquenil (hydroxychloroquine sulfate) increases intralysosomal pH, resulting in inhibition of autophagic protein degradation and accumulation of autophagosomes, which potentially leads to cell death in autophagy-dependent tumor cells (NCI Drug Dictionary).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||clear cell renal cell carcinoma||not applicable||Everolimus + Hydroxychloroquine||Phase Ib/II||Actionable||In a Phase I/II trial, treatment with the combination of Afinitor (everolimus) and Plaquenil (hydroxychloroquine) was well-tolerated, and resulted in a median progression-free survival (PFS) of 6.3 months, PFS of 6 months or greater in 45% (15/33), and partial response (PR) or stable disease (SD) greater than 3 months in 66% (22/33; 2 PR and 20 SD) of clear cell renal cell carcinoma patients (PMID: 30635337).||30635337|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03032406||Phase II||Everolimus + Hydroxychloroquine Everolimus Hydroxychloroquine||CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer||Recruiting||USA||0|
|NCT01510119||Phase Ib/II||Everolimus + Hydroxychloroquine||Autophagy Inhibition to Augment mTOR Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine in Patients With Previously Treated Renal Cell Carcinoma||Completed||USA||0|