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Therapy Name Nab-rapamycin
Synonyms
Therapy Description

Fyarro (nab-rapamycin) is nanoparticle albumin-bound rapamycin and inhibitor of mTOR that has immunosuppressant and anti-tumor activities (PMID: 24089446). Fyarro (nab-rapamycin) is FDA approved for use in patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nab-rapamycin Fyarro ABI-009|nab-sirolimus mTORC1 Inhibitor 9 Fyarro (nab-rapamycin) is nanoparticle albumin-bound rapamycin and inhibitor of mTOR that has immunosuppressant and anti-tumor activities (PMID: 24089446). Fyarro (nab-rapamycin) is FDA approved for use in patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TSC2 inact mut perivascular epithelioid cell tumor predicted - sensitive Nab-rapamycin Phase II Actionable In a Phase II trial (AMPECT), Fyarro (nab-rapamycin) treatment in patients with perivascular epithelioid cell tumors (PEComas) resulted in partial response in 20% (1/5) of patients with TSC1 mutations, 89% (8/9) of patients with TSC2 mutations, and 9% (1/11) of patients without a TSC1 or TSC2 mutation (PMID: 34637337; NCT02494570). 34637337
TSC2 inact mut Advanced Solid Tumor predicted - sensitive Nab-rapamycin Clinical Study Actionable In a clinical study, Fyarro (nab-rapamycin) treatment in patients with advanced solid tumors harboring mutations in TSC1 or TSC2 led to a partial response in 4 patients, stable disease in 2 patients and progressive disease in 1 patient of 7 enrolled patients (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 3111-3111; NCT03817515). detail...
TSC1 inact mut perivascular epithelioid cell tumor predicted - sensitive Nab-rapamycin Phase II Actionable In a Phase II trial (AMPECT), Fyarro (nab-rapamycin) treatment in patients with perivascular epithelioid cell tumors (PEComas) resulted in partial response in 20% (1/5) of patients with TSC1 mutations, 89% (8/9) of patients with TSC2 mutations, and 9% (1/11) of patients without a TSC1 or TSC2 mutation (PMID: 34637337; NCT02494570). 34637337
TSC1 inact mut Advanced Solid Tumor predicted - sensitive Nab-rapamycin Clinical Study Actionable In a clinical study, Fyarro (nab-rapamycin) treatment in patients with advanced solid tumors harboring mutations in TSC1 or TSC2 led to a partial response in 4 patients, stable disease in 2 patients, and progressive disease in 1 patient of 7 enrolled patients (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 3111-3111; NCT03817515). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05661461 Phase I Nab-rapamycin Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment Recruiting USA 0
NCT05103358 Phase II Nab-rapamycin Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1) Active, not recruiting USA 2
NCT02494570 Phase II Nab-rapamycin A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa Completed USA 0
NCT05997017 Phase II Nab-rapamycin Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer Recruiting USA 0
NCT05997056 Phase II Nab-rapamycin Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors Recruiting USA 0
NCT02646319 Phase I Nab-rapamycin Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations Completed USA 0
NCT03670030 Phase II Nab-rapamycin A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System Terminated USA 0
NCT03463265 Phase II Lomustine + Nab-rapamycin Nab-rapamycin Nab-rapamycin + Temozolomide Bevacizumab + Nab-rapamycin ABI-009 (Nab-Rapamycin) in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma Completed USA 0


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