Therapy Detail

Therapy Name Sirolimus
Therapy Description

Rapamune (sirolimus) binds to the FKBP-12 to generate an immunosuppressive complex that binds and allosterically inhibits mTOR (NCI Drug Dictionary, PMID: 25261369). Rapamune (sirolimus) is FDA approved for the prevention of renal transplant rejection and for patients with lymphangioleiomyomatosis (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sirolimus Rapamune Rapamycin mTORC1 Inhibitor 8 Rapamune (sirolimus) binds to the FKBP-12 to generate an immunosuppressive complex that binds and allosterically inhibits mTOR (NCI Drug Dictionary, PMID: 25261369). Rapamune (sirolimus) is FDA approved for the prevention of renal transplant rejection and for patients with lymphangioleiomyomatosis (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Indication other than cancer not applicable Sirolimus FDA approved Actionable Rapamune (sirolimus) is FDA approved for use in patients with lymphangioleiomyomatosis and for prophylactic immunosuppression in renal transplant patients (FDA.gov). detail...
FBXW7 inact mut breast cancer sensitive Sirolimus Preclinical - Cell line xenograft Actionable In a preclinical study, breast cancer cells harboring a FBXW7 mutation demonstrated sensitivity to Rapamune (sirolimus) in culture and in cell line xenograft models (PMID: 18787170). 18787170
FBXW7 loss colon cancer sensitive Sirolimus Preclinical Actionable In a preclinical study, Rapamune (sirolimus) inhibited epithelial-mesenchymal transition, motility, and invasiveness in colon cancer cells lacking FBXW7 in culture (PMID: 23558291) 23558291
APC inact mut colon cancer sensitive Sirolimus Preclinical Actionable In preclinical trials, Sirolimus (rapamycin) was shown effective in reducing tumors in mouse models of familial adenomatous polyposis and colon cancer with APC deficient tumors (PMID: 18768809, PMID: 20080688). 18768809 20080688
Unknown unknown Advanced Solid Tumor not applicable Sirolimus Preclinical Actionable In preclinical studies, Rapamune (sirolimus) induced apoptosis of cancer cells and increased sensitivity to Platinol (cisplatin) (PMID: 15136596). 15136596
STK11 inact mut endometrial cancer sensitive Sirolimus Preclinical Actionable In a preclinical study, Rapamune (sirolimus) reduced S6K phosphorylation and inhibited tumor growth in mouse models of STK11 (LKB1)-deficient endometrial cancer, including models with advanced tumors (PMID: 20142330). 20142330
RB1 loss retinoblastoma sensitive Sirolimus Preclinical Actionable In a preclinical study, Sirolimus (rapamycin) decreased tumor occurrence, tumor hypoxia and tumor vascularization in a retinoblastoma mouse model with functionally inactivated Rb protein (PMID: 21468343, PMID: 1689463). 21468343 1689463
RB1 loss neuroendocrine tumor sensitive Sirolimus Preclinical Actionable In a preclinical study, Sirolimus (rapamycin) slowed pituitary tumors and decreased the occurrence of thyroid tumors in Rb1+/- mice (PMID: 23454836). 23454836
Unknown unknown head and neck squamous cell carcinoma not applicable Sirolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Rapamune (sirolimus) decreased tumor growth and increased survival of cell line xenograft models of head and neck squamous cell carcinoma (PMID: 21520111). 21520111
FBXW7 inact mut fibrolamellar carcinoma sensitive Sirolimus Phase I Actionable In a Phase I study, Rapamune (sirolimus) resulted in prolonged stable disease in a patient with hepatocellular fibrolamellar carcinoma harboring a FBXW7 mutation (PMID: 24586741). 24586741
AKT1 act mut lymphoma no benefit Sirolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Rapamune (sirolimus) treatment did not improve survival in cell line xenograft animal models of lymphoma overexpressing constitutively active Akt (PMID: 18708578). 18708578
KRAS G12D TP53 R175H pancreatic ductal adenocarcinoma conflicting Sirolimus Preclinical Actionable In a preclinical study, Rapamune (sirolimus) treatment in transgenic animal models of pancreatic ductal adenocarcinoma harboring KRAS G12D and TP53 R175H resulted in proliferation of tumor cells in interior, hypovascularized tumor regions, but inhibited proliferation in outer, vascularized tumor regions, despite inhibition of mTORC signaling in both regions (PMID: 26144316). 26144316
Clinical Trial Phase Therapies Title Recruitment Status
NCT01195922 Phase Ib/II Sirolimus Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma Completed
NCT01331135 Phase I Sirolimus Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors Active, not recruiting
NCT00305682 Phase II Sirolimus Mycophenolate mofetil anti-thymocyte globulin Cyclophosphamide Fludarabine Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant Active, not recruiting
NCT01843998 Phase II Sirolimus Therapeutic Efficacy of Topical Sirolimus in Early Stage Cutaneous T-cell Lymphoma (CTCL) Withdrawn
NCT02753309 Phase 0 Sirolimus A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer Recruiting
NCT02793544 Phase II Cyclophosphamide Busulfan Sirolimus Mycophenolate mofetil Mesna Fludarabine HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide Recruiting
NCT01087554 Phase I Temsirolimus Everolimus Sirolimus Vorinostat Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer Active, not recruiting
NCT01658007 Phase I Sirolimus Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma Terminated
NCT02551718 Phase I Bosutinib Irinotecan romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Recruiting
NCT01522820 Phase I DEC-205-NY-ESO-1 fusion protein vaccine Sirolimus Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Completed
NCT01265030 Phase Ib/II Sirolimus A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis Recruiting
NCT02110069 Phase II Vincristine Sirolimus A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors Recruiting
NCT01163357 Phase I Sirolimus Bortezomib + Fludarabine + Melphalan Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma Active, not recruiting
NCT02145559 Phase I Sirolimus + Metformin Sirolimus A Pharmacodynamic Study of Sirolimus and Metformin in Patients With Advanced Solid Tumors Active, not recruiting
NCT01791088 Phase I Sirolimus Sirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery Active, not recruiting
NCT01853423 Phase I Sirolimus Tuberou Sclerosis Complex: Facial Angiofibroma Skin Cream Completed
NCT02423915 Phase Ib/II Filgrastim Rituximab Cyclophosphamide + Fludarabine + Mycophenolate mofetil Sirolimus Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention Active, not recruiting
NCT02756572 Phase I Sirolimus Mycophenolate mofetil Cyclosporine Cytarabine Melphalan Cladribine Filgrastim mitoxantrone hydrochloride Fludarabine Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myelodysplastic Syndrome or Acute Myeloid Leukemia Recruiting
NCT00513474 Phase I Rasburicase Methotrexate Sirolimus Cyclosporine Tacrolimus Filgrastim Busulfan + Cyclophosphamide + Etoposide Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant Completed
NCT03363763 Phase II Sirolimus Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex Recruiting
NCT01203722 Phase Ib/II Tacrolimus Sirolimus Cyclophosphamide + Fludarabine + Mycophenolate mofetil Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies Recruiting
NCT00923845 Phase II Sirolimus Cyclophosphamide + Pentostatin Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer Completed
NCT02722668 Phase II Cyclophosphamide + Fludarabine + Mycophenolate mofetil Sirolimus anti-thymocyte globulin UCB Transplant for Hematological DIseases Using a Non Myeloablative Prep Recruiting
NCT02009332 Phase Ib/II Sirolimus Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer Recruiting
NCT03298958 Phase III Sirolimus Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer Not yet recruiting
NCT00092222 Phase II Sirolimus Alpha 2 Interferon EPOCH Rituximab Bortezomib Doxil Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity Recruiting
NCT00602693 Phase I Sirolimus Allopurinol + Cyclophosphamide + Fludarabine T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer Completed
NCT01764607 Sirolimus Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma Terminated
NCT02583893 Phase II Sirolimus Mitoxantrone + Etoposide + Cytarabine Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia Recruiting
NCT01231412 Phase III Sirolimus Fludarabine Cyclosporine + Mycophenolate mofetil Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant Completed
NCT02790515 Phase II Sirolimus anti-thymocyte globulin Blinatumomab Tacrolimus Thiotepa Melphalan Fludarabine Cyclophosphamide Mesna Rituximab Filgrastim Provision of TCR?? T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation Recruiting