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| Therapy Name | Everolimus |
| Synonyms | |
| 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, 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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Everolimus | Afinitor | RAD001|Zortress | mTORC1 Inhibitor 9 | 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E545K PIK3CA M1043L | breast cancer | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA M1043L in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PTEN E43fs | choroid plexus carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, adjuvant Afinitor (everolimus) treatment after surgery and radiotherapy resulted in stable disease in a patient with choroid plexus carcinoma harboring PTEN E43fs, who completed 12 months of therapy and remained in remission at 60 months after initial diagnosis (PMID: 37535883). | 37535883 |
| BRAF V600E PIK3CA H1047R | thyroid gland carcinoma | resistant | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, a patient with anaplastic thyroid carcinoma co-harboring BRAF V600E and PIK3CA H1047R demonstrated resistance to treatment with Afinitor (everolimus) (PMID: 27797976). | 27797976 |
| PIK3CA E545K PIK3CA E726K | breast cancer | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA E726K in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PTEN loss | clear cell renal cell carcinoma | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, Afinitor (everolimus) inhibited cell proliferation in PTEN-deficient clear cell renal carcinoma cell lines in culture (PMID: 35165399). | 35165399 |
| TSC1 inact mut | Advanced Solid Tumor | no benefit | Everolimus | Phase II | Actionable | In a Phase II trial, Afinitor (everolimus) treatment resulted in limited activity with an objective response rate of 7% (2/30, 2 partial responses), stable disease in an additional 40% (12/30), a clinical benefit rate of 13% (4/30), a median progression-free survival of 2.3 months, and a median overall survival of 7.3 months in patients with advanced solid tumors harboring inactivating TSC1 or TSC2 mutations or activating MTOR mutations (PMID: 33727259; NCT02201212). | 33727259 |
| VHL inact mut | renal cell carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | 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 |
| PIK3CA exon10 | Her2-receptor negative breast cancer | predicted - sensitive | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated greater benefit on progression-free survival in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring PIK3CA exon 10 (reported as exon 9) mutations (HR=0.26) compared to patients harboring PIK3CA exon 21 (reported as exon 20) mutations (HR=0.56) (PMID: 26503204; NCT00863655). | 26503204 |
| TSC2 E96* | hepatocellular carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, a hepatocellular carcinoma patient harboring TSC2 E96* achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). | 30373752 |
| TSC1 E636fs | bladder carcinoma | sensitive | Everolimus | Case Reports/Case Series | Actionable | A retrospective study of a Phase II trial correlated increased sensitivity to the mTOR inhibitor Afinitor (everolimus) with TSC1 mutations in bladder cancer patients, including one patient harboring TSC1 E636fs* who had a durable complete response (PMID: 22923433). | 22923433 |
| TSC2 inact mut | Advanced Solid Tumor | no benefit | Everolimus | Phase II | Actionable | In a Phase II trial, Afinitor (everolimus) treatment resulted in limited activity with an objective response rate of 7% (2/30, 2 partial responses), stable disease in an additional 40% (12/30), a clinical benefit rate of 13% (4/30), a median progression-free survival of 2.3 months, and a median overall survival of 7.3 months in patients with advanced solid tumors harboring inactivating TSC1 or TSC2 mutations or activating MTOR mutations (PMID: 33727259; NCT02201212). | 33727259 |
| 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 |
| PIK3CA E545K | Her2-receptor negative breast cancer | no benefit | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). | 28183140 |
| PTEN negative | renal cell carcinoma | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a clinical study, negative PTEN IHC staining were detected more frequently in patients with renal cell carcinoma who responded to treatment with Afinitor (everolimus) or Torisel (temsirolimus) (odds ratio = 0.24, p=0.029) than those who did not respond (PMID: 31335987). | 31335987 |
| PIK3CA R88Q PTEN mut | endometrial cancer | sensitive | Everolimus | Preclinical | Actionable | In a preclinical study, Afinitor (everolimus) inhibited proliferation of endometrial cancer cells harboring PIK3CA R88Q and PTEN mutations in culture (PMID: 22662154). | 22662154 |
| PIK3CA act mut PTEN wild-type | breast cancer | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, 8/9 breast cancer cell lines harboring a PIK3CA activating mutation and PTEN wild-type demonstrated sensitivity to treatment with Afinitor (everolimus) in culture, resulting in decreased cell viability (PMID: 21358673). | 21358673 |
| PIK3CA H1047R | estrogen-receptor positive breast cancer | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, combination of Afinitor (everolimus) and hormone therapy resulted in improved median progression-free survival (8.8 vs 4.1 months, p=0.02) in patients with hormone receptor-positive metastatic breast cancer harboring PIK3CA H1047R (n=6) compared to patients without PIK3CA H1047R (n=10) (PMID: 31088410). | 31088410 |
| PIK3CA act mut PTEN dec exp | renal cell carcinoma | no benefit | Everolimus | Case Reports/Case Series | 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 the presence (n=21) or absence (n=17) of PIK3CA activating mutations (PMID: 26951309). | 26951309 |
| TSC2 Q1178* | thyroid cancer | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, a thyroid cancer patient harboring TSC2 Q1178* demonstrated an 18-month response to Afinitor (everolimus) (PMID: 25295501; NCT00936858). | 25295501 |
| PIK3CA exon21 | Her2-receptor negative breast cancer | no benefit | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated greater benefit on progression-free survival in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring PIK3CA exon 10 (reported as exon 9) mutations (HR=0.26) compared to patients harboring PIK3CA exon 21 (reported as exon 20) mutations (HR=0.56) (PMID: 26503204; NCT00863655). | 26503204 |
| TSC1 mutant | renal cell carcinoma | conflicting | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). | 31335987 |
| TSC1 mutant | renal cell carcinoma | conflicting | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, TSC1, TSC2, or MTOR mutation status was not associated with progression-free survival in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). | 30327302 |
| TSC1 inact mut | renal cell carcinoma | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). | 26831717 |
| PIK3CA M1043I PIK3CA amp | bladder urothelial carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, a patient with metastatic urothelial bladder cancer harboring PIK3CA M1043I and PIK3CA amplification (copy number >20), as well as amplification of CCND1 and loss of CDKN2A and CDKN2B, was treated with Afinitor (everolimus) and achieved a complete response including remission of lymph node metastases, and remained progression-free at 6 months (PMID: 33745098). | 33745098 |
| PIK3CA H1047R | Her2-receptor negative breast cancer | no benefit | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). | 28183140 |
| 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... |
| BRAF V600E PTEN loss | melanoma | predicted - resistant | Everolimus | Case Reports/Case Series | Actionable | In a retrospective analysis, a melanoma patient harboring PTEN loss and BRAF V600E demonstrated resistance to Afinitor (everolimus) treatment, resulting in progressive disease (PMID: 20664172). | 20664172 |
| 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 |
| 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 |
| TSC2 inact mut | renal cell carcinoma | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). | 26831717 |
| RET M918T | medullary thyroid carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | 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 harbored a RET M918T mutation (PMID: 26294908; NCT01118065). | 26294908 |
| PTEN loss | renal cell carcinoma | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, 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 |
| PIK3CA mutant | Her2-receptor negative breast cancer | no benefit | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), the presence of PIK3CA mutations did not significantly affect the efficacy of Afinitor (everolimus) in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer, with a HR for progression-free survival of 0.37 in PIK3CA wild-type group and a HR of 0.51 (p=0.35) in patients with PIK3CA mutations (PMID: 26503204; NCT00863655). | 26503204 |
| PIK3CA E545K | breast cancer | sensitive | Everolimus | Preclinical | Actionable | In a preclinical study, breast cancer cell lines harboring a PIK3CA E545K mutation had increased sensitivity to Afinitor (everolimus) in culture (PMID: 20664172). | 20664172 |
| RET C620R | medullary thyroid carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | 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 harboring a RET C620R mutation (PMID: 26294908; NCT01118065). | 26294908 |
| TSC1 mutant | bladder carcinoma | sensitive | Everolimus | Phase II | Actionable | A retrospective study of a Phase II trial correlated increased sensitivity to the mTOR inhibitor Afinitor (everolimus) with TSC1 mutations in bladder cancer patients (PMID: 22923433). | 22923433 |
| RET mutant | medullary thyroid carcinoma | sensitive | Everolimus | Phase II | Actionable | In a Phase II 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; NCT01118065). | 26294908 |
| NRAS G13D | B-cell acute lymphoblastic leukemia | no benefit | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, a pediatric patient with relapsed B-cell acute lymphoblastic leukemia harboring NRAS G13D, who also harbored SETD2 L1778fs* and an IKZF1 deletion, was treated with Afinitor (everolimus) in combination with chemotherapy and experienced persistent disease, and the patient died 6 months later (PMID: 33563661; NCT02670525). | 33563661 |
| TSC2 D1598fs TSC2 D1690fs | hepatocellular carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, a hepatocellular carcinoma patient harboring TSC2 D1598fs and TSC2 D1690fs achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). | 30373752 |
| TSC2 R611W | giant cell glioblastoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, Afinitor (everolimus) treatment with adjuvant electromagnetic field therapy resulted in complete remission ongoing 33 months after diagnosis in a patient with gigantocellular glioblastoma harboring TSC2 R611W who was previously treated with surgical resection and radiotherapy (PMID: 31154346). | 31154346 |
| 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 |
| TSC2 mutant | subependymal giant cell astrocytoma | predicted - sensitive | Everolimus | Phase III | Actionable | In a Phase III trial (EXIST-1), Afinitor (everolimus) treatment resulted in a 50% or more tumor reduction in 35% (27/78) of adult and pediatric patients diagnosed with tuberous sclerosis complex and had subependymal giant cell astrocytoma, compared to 0% (0/39) in the placebo group, 85% (99/117) of the patients harbored mutations in TSC1 and/or TSC2 (PMID: 23158522; NCT00789828). | 23158522 |
| PIK3CA mutant | Erdheim-Chester disease | sensitive | Everolimus | Guideline | Actionable | Afinitor (everolimus) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring PIK3CA mutations (NCCN.org). | detail... |
| PIK3CA E542K | Her2-receptor negative breast cancer | no benefit | Everolimus | Phase III | Actionable | In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). | 28183140 |
| PTEN N323fs | castration-resistant prostate carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical case study, Afinitor (everolimus) treatment resulted in stable disease for eight months in a patient with castration-resistant prostate cancer harboring PTEN N323fs*21 who had previously progressed on several lines of therapy (PMID: 32399016). | 32399016 |
| PIK3CA H1047R | progesterone-receptor positive breast cancer | predicted - sensitive | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, combination of Afinitor (everolimus) and hormone therapy resulted in improved median progression-free survival (8.8 vs 4.1 months, p=0.02) in patients with hormone receptor-positive metastatic breast cancer harboring PIK3CA H1047R (n=6) compared to patients without PIK3CA H1047R (n=10) (PMID: 31088410). | 31088410 |
| TSC1 R98* | hepatocellular carcinoma | predicted - sensitive | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, a hepatocellular carcinoma patient harboring TSC1 R98* achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). | 30373752 |
| PTEN dec exp | renal cell carcinoma | no benefit | Everolimus | Case Reports/Case Series | 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 |
| 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 |
| TSC2 mutant | renal cell carcinoma | conflicting | Everolimus | Clinical Study - Cohort | Actionable | In a retrospective analysis, TSC1, TSC2, or MTOR mutation status was not associated with progression-free survival in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). | 30327302 |
| TSC2 mutant | renal cell carcinoma | conflicting | Everolimus | Case Reports/Case Series | Actionable | In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). | 31335987 |
| PIK3CA E726K PIK3CA H1047R | breast cancer | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E726K and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA act mut | Advanced Solid Tumor | sensitive | Everolimus | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Afinitor (everolimus) demonstrated efficacy in multiple cancer cell lines in culture and xenograft models with PIK3CA activating mutations (PMID: 20664172). | 20664172 |
| PBRM1 inact mut | renal cell carcinoma | no benefit | Everolimus | Case Reports/Case Series | Actionable | In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma had no difference in progression-free survival when stratified by the presence (n=6) or absence (n=22) of deleterious PBRM1 mutation when treated with Afinitor (everolimus) (PMID: 26951309). | 26951309 |
| 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 |
| PTEN loss | transitional cell carcinoma | predicted - resistant | Everolimus | Case Reports/Case Series | 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, while 0% (0/6) of patients with controlled disease demonstrated evidence of PTEN loss (PMID: 22473592). | 22473592 |
| PIK3CA E453Q PIK3CA H1047R | breast cancer | sensitive | Everolimus | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E453Q and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| 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 |
| TSC1 mutant | subependymal giant cell astrocytoma | predicted - sensitive | Everolimus | Phase III | Actionable | In a Phase III trial (EXIST-1), Afinitor (everolimus) treatment resulted in a 50% or more tumor reduction in 35% (27/78) of adult and pediatric patients diagnosed with tuberous sclerosis complex and had subependymal giant cell astrocytoma, compared to 0% (0/39) in the placebo group, 85% (99/117) of the patients harbored mutations in TSC1 and/or TSC2 (PMID: 23158522; NCT00789828). | 23158522 |
| PBRM1 mutant | clear cell renal cell carcinoma | conflicting | Everolimus | Clinical Study - Cohort | Actionable | In a clinical study, PBRM1 truncating mutations were not associated with progression-free survival or overall survival in clear cell renal cell carcinoma patients treated with Afinitor (everolimus) (n=193) (PMID: 31486842). | 31486842 |
| PBRM1 mutant | clear cell renal cell carcinoma | conflicting | Everolimus | Phase II | Actionable | In a Phase II trial (RECORD-3), PBRM1 mutations were associated with longer first-line progression free survival (12.8 vs 5.5 months) in first-line Afinitor (everolimus)-treated clear cell renal cell carcinoma patients compared to first-line Sutent (sunitinib)-treated patients (PMID: 27751729). | 27751729 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02254239 | Phase I | Everolimus | Everolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma | Terminated | USA | 0 |
| NCT02269670 | Phase II | Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole | Phase II Study of Everolimus Beyond Progression | Terminated | USA | 0 |
| NCT01133678 | Phase II | Cetuximab + Cisplatin + Paclitaxel Everolimus | Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck | Terminated | USA | 0 |
| NCT01827384 | Phase II | Adavosertib + Carboplatin Temozolomide + Veliparib Everolimus Trametinib | Molecular Profiling-Based Targeted Therapy in Treating Patients With Advanced Solid Tumors | Completed | USA | 0 |
| NCT01797523 | Phase II | Letrozole Everolimus Metformin | RAD/Letrozole/Metformin | Active, not recruiting | USA | 0 |
| NCT00610948 | Phase I | Everolimus Panitumumab | Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Solid Tumors That Did Not Respond to Treatment | Completed | USA | 0 |
| NCT02201212 | Phase II | Everolimus | Everolimus for Cancer With TSC1 or TSC2 Mutation | Completed | USA | 0 |
| NCT05725200 | Phase II | Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) | Recruiting | NOR | 0 |
| NCT01865747 | Phase III | Everolimus Cabozantinib | A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma | Completed | USA | TUR | SWE | SVK | POL | NLD | ITA | IRL | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | ARG | 5 |
| NCT01215136 | Phase II | Everolimus Paclitaxel | First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma | Terminated | USA | 0 |
| NCT04199026 | Phase I | Irinotecan Doxorubicin Ifosfamide Temozolomide Temsirolimus Ganitumab Pazopanib Everolimus Vincristine Sulfate | Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma | Not yet recruiting | USA | 0 |
| NCT01603004 | Phase I | Everolimus Sunitinib | Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors | Completed | USA | 0 |
| NCT00831480 | Phase II | Everolimus | Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal | Terminated | USA | 0 |
| NCT04665739 | Phase II | Everolimus lutetium Lu 177 dotatate | Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors | Recruiting | USA | 0 |
| 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 | Completed | USA | 0 |
| NCT02456857 | Phase II | Bevacizumab Everolimus Pegylated liposomal doxorubicin | Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative | Completed | USA | 0 |
| NCT04185831 | Phase II | Atezolizumab Niraparib Cobimetinib Everolimus | A MolEcularly Guided Anti-Cancer Drug Off-Label Trial (MEGALiT) | Active, not recruiting | SWE | 0 |
| NCT02504892 | Phase II | Everolimus | Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer | Terminated | USA | 0 |
| NCT01120249 | Phase III | Everolimus | S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (S0931) | Active, not recruiting | USA | 1 |
| NCT01197170 | Phase I | Erlotinib Everolimus Sorafenib Anastrozole Bevacizumab | Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance | Completed | USA | 0 |
| NCT01931163 | Phase II | Everolimus | NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer | Completed | USA | 0 |
| NCT05188118 | Phase I | Cabozantinib Nivolumab Everolimus Ipilimumab Lenvatinib | Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma | Recruiting | USA | 0 |
| 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 | Active, not recruiting | USA | 0 |
| NCT02023905 | Phase II | Temozolomide Everolimus | Everolimus With and Without Temozolomide in Adult Low Grade Glioma | Terminated | USA | 0 |
| NCT04591431 | Phase II | Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) | Active, not recruiting | ITA | 0 |
| NCT02143726 | Phase II | Sorafenib Everolimus | Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Thyroid Cancer | Unknown status | USA | 0 |
| NCT01111058 | Phase II | Everolimus | Everolimus Versus Placebo in Head and Neck Cancer | Terminated | USA | 0 |
| NCT05476939 | Phase III | Everolimus ONC201 | Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) | Recruiting | SWE | FRA | ESP | DNK | 0 |
| NCT05773274 | Phase Ib/II | Everolimus lutetium Lu 177 dotatate | Comparing Retreatment of 177Lu-DOTATATE PRRT Versus Everolimus in Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial | Recruiting | USA | CAN | 0 |
| NCT03163667 | Phase II | Everolimus + Telaglenastat Everolimus | CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC | Completed | USA | 0 |
| NCT01637090 | Phase II | Everolimus | Everolimus in Treating Cutaneous T-cell Lymphoma | Terminated | USA | 0 |
| NCT02155920 | Phase II | Everolimus | Everolimus for Children With Recurrent or Progressive Ependymomaildren With Recurrent or Progressive Ependymoma | Completed | USA | 0 |
| NCT01087554 | Phase I | Temsirolimus Everolimus Sirolimus Vorinostat | Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer | Active, not recruiting | USA | 0 |
| NCT01217931 | Phase II | Everolimus Pazopanib Bevacizumab | Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy | Active, not recruiting | USA | 0 |
| NCT02205515 | Phase Ib/II | Everolimus | An Open Label, Single-Centre, Phase II Study of Everolimus With EBRT for the Treatment of mNET Liver Metastasis | Completed | CAN | 0 |
| NCT02560012 | Phase II | Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib | Personalized Targeted Inhibitors Treatment in Renal Cell Cancer | Terminated | USA | 0 |
| NCT02724020 | Phase II | Sapanisertib + Serabelisib Sapanisertib Everolimus | MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma | Completed | USA | POL | ITA | GBR | FRA | ESP | CZE | CAN | 0 |
| NCT03578432 | Phase I | Everolimus | Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy | Terminated | USA | 0 |
| 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 | USA | 0 |
| NCT01334502 | Phase I | Everolimus Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate | Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma | Completed | USA | 0 |
| NCT01345136 | Phase II | Everolimus | Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma | Terminated | USA | 0 |
| NCT01270321 | Phase II | Pasireotide Everolimus | A Trial of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer | Completed | USA | 0 |
| NCT04919226 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide | Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) | Recruiting | USA | SWE | NLD | ITA | GBR | FRA | ESP | DEU | AUS | 1 |
| NCT01523977 | Phase I | Prednisone Everolimus Vincristine Sulfate Doxorubicin Pegaspargase | Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL | Completed | USA | 0 |
| NCT02387099 | Phase II | Everolimus | Dose EScalation Induction of EvERolimus (Desiree) | Completed | DEU | 0 |
| NCT03458221 | Phase II | Itraconazole Everolimus Letrozole Bicalutamide | Signal TrAnsduction Pathway Activity Analysis in OVarian cancER (STAPOVER) | Recruiting | NLD | 0 |
| NCT06472388 | Phase II | Everolimus | Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors (EVENET) | Recruiting | BRA | 0 |
| 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 | Active, not recruiting | USA | 0 |
| NCT00912340 | Phase II | Everolimus Trastuzumab | Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer | Completed | USA | 0 |
| NCT01674140 | Phase III | Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane | S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3) | Active, not recruiting | USA | 1 |
| 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 | Terminated | USA | 0 |
| NCT02273752 | Phase II | Everolimus | Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer | Terminated | USA | 0 |
| NCT02332902 | Phase II | Everolimus | Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T | Completed | USA | 0 |
| NCT02236572 | Phase II | Everolimus | Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score | Terminated | USA | 0 |
| NCT02397083 | Phase II | Everolimus | Phase II Study of Intrauterine Device (IUD) Alone or in Combination With Everolimus in Endometrial Cancer | Active, not recruiting | USA | 0 |
| NCT06126588 | Phase II | Everolimus | Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial (ELUMEN) | Not yet recruiting | FRA | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Terminated | USA | 0 |
| NCT05477576 | Phase Ib/II | Everolimus Lanreotide acetate RYZ101 Sunitinib Octreotide acetate | Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (ACTION-1) | Recruiting | USA | NLD | FRA | ESP | CAN | BRA | BEL | 0 |
| NCT01218555 | Phase I | Lenalidomide Everolimus | Study of Everolimus (RAD001)in Combination With Lenalidomide | Completed | USA | 0 |
| NCT03049189 | Phase III | 177Lu-edotreotide Everolimus | Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE) | Active, not recruiting | USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | CZE | CHE | BEL | AUT | AUS | 1 |
| NCT02031536 | Phase II | Everolimus | Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery | Terminated | USA | 0 |
| NCT01880749 | Phase I | Everolimus | Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas | Completed | USA | 0 |
| NCT01665768 | Phase II | Rituximab Everolimus | Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma | Completed | USA | 0 |
| 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 | USA | 0 |
| NCT02015728 | Phase I | Erlotinib Everolimus Dasatinib Etoposide + Temozolomide Sorafenib | Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors | Unknown status | USA | 0 |
| NCT02352844 | Phase II | Everolimus | Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations | Completed | USA | 0 |
| 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 | USA | 0 |
| NCT02539459 | Phase II | Everolimus | Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus | Terminated | USA | 0 |
| NCT01734512 | Phase II | Everolimus | PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children | Completed | USA | 0 |
| NCT02687958 | Phase II | Everolimus | Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin | Active, not recruiting | ITA | 0 |
| NCT05432518 | Phase I | Olaparib Palbociclib Afatinib Everolimus Dasatinib | GBM Personalized Trial | Recruiting | CAN | 0 |
| NCT01508104 | Phase Ib/II | Dactolisib + Everolimus Everolimus | Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors | Terminated | USA | 0 |
| NCT01700400 | Phase I | Carboplatin Everolimus Bevacizumab Pemetrexed Disodium | Study of Everolimus, Pemetrexed, Carboplatin, and Bevacizumab to Treat Stage IV Lung Cancer | Completed | USA | 0 |
| NCT05918302 | Phase III | 177Lu-edotreotide Everolimus | Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. (LEVEL) | Recruiting | ITA | FRA | ESP | 0 |
| NCT04195750 | Phase III | Belzutifan Everolimus | A Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) | Active, not recruiting | USA | TUR | SWE | NOR | ITA | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | 8 |
| NCT00823459 | Phase II | Everolimus | Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma | Completed | USA | 0 |
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