Therapy Detail

Therapy Name Everolimus
Therapy Description

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, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).

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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, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN loss Advanced Solid Tumor no benefit Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment in patients with advanced solid tumors harboring PTEN loss did not reach its primary endpoint, resulting in only stable disease or progressive disease (PMID: 28330462). 28330462
HRAS mutant Advanced Solid Tumor predicted - sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, human solid tumor cell lines harboring HRAS mutations demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) in culture compared to cell lines with wild-type HRAS (PMID: 26544513). 26544513
Unknown unknown estrogen-receptor positive breast cancer not applicable Everolimus Preclinical - Cell culture Actionable In a preclinical study, treatment with Afinitor (everolimus) resulted in decreased cell proliferation, reduced anchorage-independent cell growth and a decrease in PI3K/Akt/mTOR pathway signaling in estrogen-receptor positive breast cancer cell lines resistant to aromatase inhibitors (PMID: 27421652). 27421652
Unknown unknown lymphoma not applicable Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment resulted in an overall response rate of 44% (7/16) in T-cell lymphoma patients, with a median progression-free survival of 4.1 months and a median overall survival of 10.2 months (PMID: 25921059). 25921059
STK11 D194E STK11 loss pancreatic cancer sensitive Everolimus Clinical Study Actionable In a clinical case study, a pancreatic cancer patient with Peutz-Jeghers syndrome harboring STK11 D194E and loss of heterozygosity of the other STK11 allele in the tumor achieved a partial response following treatment with Afinitor (everolimus), but progressed after 9 months (PMID: 21189378). 21189378
HRAS G12V Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS G12V demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
PTEN dec exp renal cell carcinoma no benefit Everolimus Phase II Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Afinitor (everolimus) had no difference in progression free survival when stratified by high expression (n=17) and low expression (n=21) of Pten (PMID: 26951309). 26951309
PTEN mutant endometrial cancer sensitive Everolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Afinitor (everolimus) inhibited growth of endometrial cancer cells harboring a PTEN nonsense mutation in culture and in xenograft models (PMID: 22662154). 22662154
PTEN loss breast cancer resistant Everolimus Preclinical - Cell culture Actionable In a preclinical study, 10/12 breast cancer cell lines with PTEN loss demonstrated resistance to Afinitor (everolimus) in culture (PMID: 21358673). 21358673
Unknown unknown renal cell carcinoma not applicable Everolimus FDA approved Actionable In a Phase III trial that supported FDA approval, Afinitor (everolimus) improved progression-free survival in patients with metastatic renal cell carcinoma (PMID: 23659703). 23659703
Unknown unknown renal cell carcinoma not applicable Everolimus Phase II Actionable In a Phase II clinical trial, Apitolisib (GDC-0980) was inferior to Afinitor (everolimus) by median PFS, 3.7 months (n=42) vs. 6.1 months (n=43), respectively and overall survival trended lower as well in patients with metastatic renal cell carcinoma (PMID: 26951309). 26951309
Unknown unknown oral squamous cell carcinoma not applicable Everolimus Preclinical Actionable In a preclinical study, Afinitor (everolimus) inhibited growth and mTOR signaling in oral squamous cell carcinoma cell lines (PMID: 25682238). 25682238
RET mutant thyroid medullary carcinoma sensitive Everolimus Phase II Actionable In a Phase II clinical trial, Afinitor (everolimus) treatment resulted in stable disease in 71% (5/7) of medullary thyroid cancer patients, including patients harboring RET mutations, with median progression-free survival of 33 weeks (PMID: 26294908). 26294908
Unknown unknown non-small cell lung carcinoma not applicable Everolimus Phase Ib/II Actionable In a Phase Ib trial, Afinitor (everolimus) demonstrated safety and preliminary efficacy in patients with non-small cell lung cancer (PMID: 25673697). 25673697
VHL inact mut renal cell carcinoma predicted - sensitive Everolimus Phase II Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Afinitor (everolimus) had a trend towards improved in progression free survival when stratified by the presence (median PFS=8.6 months, n=15) or absence (median PFS=5.5 months, n=16) of deleterious VHL mutations (PMID: 26951309). 26951309
Unknown unknown neuroendocrine tumor not applicable Everolimus FDA approved Actionable In a Phase III trial supporting FDA approval, Afinitor (everolimus) treatment significantly improved median progression-free survival (11.0 months) comparing to placebo (3.9 months) in patients with neuroendocrine tumours of the lung or gastrointestinal tract origin (PMID: 26703889). 26703889
PTEN loss transitional cell carcinoma resistant Everolimus Phase II Actionable In a Phase II trial, 57% (8/14) of transitional cell carcinoma patients that demonstrated uncontrolled disease after treatment with Afinitor (everolimus) harbored PTEN loss compared to 0% of patients with controlled disease demonstrating no evidence of PTEN loss (PMID: 22473592). 22473592
PTEN loss renal cell carcinoma predicted - sensitive Everolimus Clinical Study Actionable In a retrospective study, loss of PTEN expression was associated with improved progression-free survival compared to PTEN positive (10.5 vs 5.3 months) in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). 30327302
BRAF V600E PTEN loss melanoma resistant Everolimus Clinical Study Actionable In a clinical study, a melanoma patient harboring PTEN loss and BRAF V600E demonstrated resistance to Afinitor (everolimus) treatment, resulting in progressive disease (PMID: 20664172). 20664174 20664172
Unknown unknown stomach cancer no benefit Everolimus Phase III Actionable In a Phase III trial, Afinitor (everolimus) did not significantly improve overall survival (5.4 vs 4.3 months) and progression free survival (1.7 vs 1.4 months) over placebo in previously treated advanced gastric cancer patients (PMID: 24043745). 24043745
Unknown unknown islet cell tumor not applicable Everolimus FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Afinitor (everolimus) prolonged progression-free survival in patients with pancreatic neuroendocrine tumors (PMID: 23659703). 23659703
HRAS Q61L Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS Q61L demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
HRAS Q61R Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS Q61R demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
Unknown unknown thyroid cancer not applicable Everolimus Phase II Actionable In a Phase II trial, treatment with Afinitor (everolimus) resulted in a median progression-free survival (PFS) of 12.9 months, 2-year PFS of 23.6%, and 2-year overall survival of 73.5% in patients with differentiated thyroid cancer, and a partial response in a patient with anaplastic thyroid cancer (ATC), and disease stability for 26 months in another ATC patient (PMID: 29301825). 29301825
Unknown unknown endometrial cancer not applicable Everolimus Phase II Actionable In a Phase II trial, the mTOR inhibitor Afinitor (everolimus) demonstrated efficacy and tolerability in patients with chemotherapy-refractory advanced or metastatic endometrial cancer (PMID: 23612453). 23612453
KRAS mutant Advanced Solid Tumor resistant Everolimus Clinical Study Actionable In a clinical study, KRAS mutations were associated with resistance to Afinitor (everolimus) in patients with advanced solid tumors (PMID: 20664172). 20664172
RET M918T thyroid medullary carcinoma sensitive Everolimus Phase II Actionable In a Phase II clinical trial, Afinitor (everolimus) treatment resulted in stable disease in 71% (5/7) of medullary thyroid cancer patients, and 4 of the 7 patients carried a RET M918T mutation (PMID: 26294908). 26294908
Unknown unknown malignant glioma not applicable Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment resulted in a 6-month progression free survival rate of 87% and 55% in patients with WHO grade II and III/IV glioma, respectively (Neuro Oncol (2016) 18 (suppl 6): vi8-vi9.). detail...
Unknown unknown transitional cell carcinoma not applicable Everolimus Phase II Actionable In a Phase II trial, treatment with Afinitor (everolimus) in patients with transitional cell carcinoma resulted in 2 patients with a partial response, 8 patients with stable disease, and 27 patients with progressive disease, and resulted in a median progression free survival of 61 days and a median overall survival of 101 days (PMID: 22473592). 22473592
Unknown unknown colon adenocarcinoma not applicable Everolimus Preclinical - Cell line xenograft Actionable In preclinical studies, the mTOR inhibitor Afinitor (everolimus) inhibited tumor growth in colon cancer cell line xenograft models (PMID: 20890178). 20890178
MPL W515L myelofibrosis sensitive Everolimus Phase II Actionable In a phase II study of patients with myelofibrosis, 2/2 patients with MPL W515L/K had tumor response to everolimus, with one patient displaying clinical benefit (PMID: 21725052). 21725052
RET C620R thyroid medullary carcinoma sensitive Everolimus Phase II Actionable In a Phase II clinical trial, Afinitor (everolimus) treatment resulted in stable disease of 116 weeks in a MEN2A patient with medullary thyroid cancer carrying a RET C620R mutation (PMID: 26294908). 26294908
Unknown unknown malignant peripheral nerve sheath tumor not applicable Everolimus Preclinical - Cell line xenograft Actionable In a preclinical study, malignant peripheral nerve sheath cell line xenograft models treated with Afinitor (everolimus) demonstrated a 76% decrease in tumor growth (PMID: 18483311). 18483311
Unknown unknown breast cancer not applicable Everolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Afinitor (everolimus) inhibited the growth of a breast cancer cell line in culture and resulted in decreased tumor volume in a cell line xenograft model (PMID: 26351208). 26351208
VHL mutant renal cell carcinoma sensitive Everolimus Phase I Actionable In a Phase I study, Afinitor (everolimus), as compared to Apitolisib (GDC-0980), resulted in a greater progression free survival and overall survival in patients with renal cell carcinoma harboring VHL mutations (J Clin Oncol 32:5s, 2014 (suppl; abstr 4525)). detail...
MPL W515K myelofibrosis sensitive Everolimus Phase II Actionable In a phase II study of patients with myelofibrosis, 2/2 patients with MPL W515L/K had tumor response to everolimus, with one patient displaying clinical benefit (PMID: 21725052). 21725052
Clinical Trial Phase Therapies Title Recruitment Status
NCT00912340 Phase II Everolimus Trastuzumab Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer Completed
NCT03352427 Phase II Dasatinib + Everolimus Everolimus Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring PDGFR/FGFR Alterations Recruiting
NCT02143726 Phase II Sorafenib Everolimus Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Thyroid Cancer Recruiting
NCT02031536 Phase II Everolimus Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery Terminated
NCT01345136 Phase II Everolimus Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma Active, not recruiting
NCT02560012 Phase II Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib Personalized Targeted Inhibitors Treatment in Renal Cell Cancer Terminated
NCT01270321 Phase II Pasireotide Everolimus A Trial of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer Active, not recruiting
NCT02089334 Phase Ib/II Everolimus + RX-0201 Everolimus Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer Terminated
NCT02397083 Phase II Everolimus Phase II Study of Intrauterine Device (IUD) Alone or in Combination With Everolimus in Endometrial Cancer Recruiting
NCT01334502 Phase I Everolimus CHOP + Rituximab Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma Completed
NCT01637090 Phase II Everolimus Everolimus in Treating Cutaneous T-cell Lymphoma Terminated
NCT02539459 Phase II Everolimus Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus Terminated
NCT02504892 Phase II Everolimus Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer Terminated
NCT01523977 Phase I Prednisone Everolimus Vincristine Doxorubicin Pegaspargase Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL Active, not recruiting
NCT01508104 Phase Ib/II BEZ235 + Everolimus Everolimus Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors Terminated
NCT01217931 Phase II Everolimus Pazopanib Bevacizumab Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy Active, not recruiting
NCT01827384 Phase II MK-1775 + Carboplatin Veliparib + Temozolomide Everolimus Trametinib Molecular Profiling-Based Targeted Therapy in Treating Patients With Advanced Solid Tumors Suspended
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
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
NCT00610948 Phase I Everolimus Panitumumab Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Solid Tumors That Did Not Respond to Treatment Completed
NCT02254239 Phase I Everolimus Everolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma Active, not recruiting
NCT02352844 Phase II Everolimus Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations Completed
NCT02236572 Phase II Everolimus Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score Completed
NCT02273752 Phase II Everolimus Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer Terminated
NCT02023905 Phase II Temozolomide Everolimus Everolimus With and Without Temozolomide in Adult Low Grade Glioma Recruiting
NCT02724020 Phase II MLN1117 + Sapanisertib Sapanisertib Everolimus MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Active, not recruiting
NCT02205515 Phase Ib/II Everolimus An Open Label, Single-Centre, Phase II Study of Everolimus With EBRT for the Treatment of mNET Liver Metastasis Recruiting
NCT01665768 Phase II Rituximab Everolimus Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Active, not recruiting
NCT02315625 Phase II Everolimus Sunitinib Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Active, not recruiting
NCT01931163 Phase II Everolimus NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer Active, not recruiting
NCT01797523 Phase II Letrozole Everolimus Metformin RAD/Letrozole/Metformin Active, not recruiting
NCT03578432 Phase I Everolimus Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy Recruiting
NCT02155920 Phase II Everolimus Everolimus for Children With Recurrent or Progressive Ependymomaildren With Recurrent or Progressive Ependymoma Completed
NCT01865747 Phase III Everolimus Cabozantinib A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma Active, not recruiting
NCT01603004 Phase I Everolimus Sunitinib Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors Recruiting
NCT01197170 Phase I Erlotinib Everolimus Sorafenib Anastrozole Bevacizumab Hormone Blockade in Combination With Targeted Agents Active, not recruiting
NCT00823459 Phase II Everolimus Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma Completed
NCT01218555 Phase I Lenalidomide Everolimus Study of Everolimus (RAD001)in Combination With Lenalidomide Completed
NCT02081755 Tacrolimus Everolimus Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer Recruiting
NCT02520063 Phase Ib/II Letrozole Carotuximab Everolimus Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Recruiting
NCT01215136 Phase II Everolimus Paclitaxel First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma Active, not recruiting
NCT02450175 Phase I Letrozole Everolimus Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls Unknown status
NCT01120249 Phase III Everolimus S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery Active, not recruiting
NCT01133678 Phase II Cetuximab + Cisplatin + Paclitaxel Everolimus Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck Active, not recruiting
NCT02599324 Phase Ib/II Docetaxel Ibrutinib Everolimus Paclitaxel Cetuximab A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors Recruiting
NCT01548807 Phase I Everolimus Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy Completed
NCT02201212 Phase II Everolimus Everolimus for Cancer With TSC1 or TSC2 Mutation Active, not recruiting
NCT03163667 Phase II CB-839 + Everolimus Everolimus CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC Active, not recruiting
NCT00831480 Phase II Everolimus Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal Terminated
NCT01674140 Phase III Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer Recruiting
NCT01734512 Phase II Everolimus PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children Recruiting
NCT02015728 Phase I Erlotinib Everolimus Dasatinib Temozolomide + Etoposide Sorafenib Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors Unknown status
NCT00976573 Everolimus Bevacizumab Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma Completed
NCT01111058 Phase II Everolimus Everolimus Versus Placebo in Head and Neck Cancer Active, not recruiting
NCT01087554 Phase I Temsirolimus Everolimus Sirolimus Vorinostat Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer Active, not recruiting
NCT01880749 Phase I Everolimus Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas Active, not recruiting
NCT01700400 Phase I Carboplatin Everolimus Bevacizumab Pemetrexed Study of Everolimus, Pemetrexed, Carboplatin, and Bevacizumab to Treat Stage IV Lung Cancer Completed
NCT02531932 Phase II Carboplatin Everolimus Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer Recruiting
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Everolimus and Hormone Therapy in Treating Patients With Advanced Hormone Receptor Positive Breast Cancer That Has Progressed or Recurred on Everolimus and Exemestane Therapy Active, not recruiting
NCT02332902 Phase II Everolimus Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T Completed