Everolimus

Generic Name: Everolimus

Brand Names: Afinitor, Votubia, Zortress

Drug Type: Small Molecule

Chemical Formula: C_₅₃H_₈₃NO_₁₄

CAS Number: 159351-69-6

Unique Ingredient Identifier: 9HW64Q8G6G

Background: Everolimus is a derivative of Rapamycin (sirolimus), and works similarly to Rapamycin as an mTOR (mammalian target of rapamycin) inhibitor. It is currently used as an immunosuppressant to prevent rejection of organ transplants. In a similar fashion to other mTOR inhibitors Everolimus' effect is solely on the mTORC1 protein and not on the mTORC2 protein.

Indication: Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.
...

Associated Conditions: Heart Transplant Rejection, Kidney Transplant Rejection, Liver Transplant Rejection, Progressive Neuroendocrine Tumors of pancreatic origin, Renal angiomyolipoma, tuberous sclerosis complex, Subependymal giant cell astrocytoma, tuberous sclerosis complex, Waldenstrom's Macroglobulinemia Refractory, Advanced Carcinoid tumor, Locally advanced Progressive Neuroendocrine Tumors of gastrointestinal origin, Locally advanced lung origin Progressive Neuroendocrine Tumors, Metastatic gastrointestinal origin Progressive Neuroendocrine Tumors, Metastatic lung origin Progressive Neuroendocrine Tumors, Refractory Advanced Renal Cell Carcinoma, Refractory, advanced Breast cancer, Unresectable gastrointestinal origin Progressive Neuroendocrine Tumors, Unresectable lung origin Progressive Neuroendocrine Tumors

Associated Therapies: -

Clinical Trials

Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study

Phase 2

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Tacrolimus
Drug: Everolimus

First Posted Date: 2016-11-22

Last Posted Date: 2019-03-01

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Target Recruit Count: 28

Registration Number: NCT02970630

Locations: 🇮🇹
Azienda Ospedaliera di Padova, Padova, Italy
🇮🇹
Ospedale Maggiore Policlinico, Milano, Italy
🇮🇹
Policlinico "A. Gemelli", Rome, Italy

and more 3 locations

Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

Phase 3

Active, not recruiting

Conditions: Tuberous Sclerosis Complex

Interventions: Drug: everolimus

First Posted Date: 2016-11-11

Last Posted Date: 2024-05-14

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 206

Registration Number: NCT02962414

Locations: 🇬🇧
Novartis Investigative Site, York, United Kingdom

Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

Not Applicable

Completed

Conditions: Immunosuppression

Interventions: Drug: Tacrolimus
Drug: Prednisone
Drug: Everolimus
Drug: Mycophenolate mofetil

First Posted Date: 2016-11-03

Last Posted Date: 2019-12-24

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 40

Registration Number: NCT02954198

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

Phase 2

Completed

Conditions: Non Clear Cell Renal Cell Carcinoma (nccRCC)

Interventions: Drug: lenvatinib
Drug: everolimus

First Posted Date: 2016-09-27

Last Posted Date: 2023-01-17

Lead Sponsor: Eisai Inc.

Target Recruit Count: 41

Registration Number: NCT02915783

Locations: 🇺🇸
Washington University, Saint Louis, Missouri, United States
🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

and more 5 locations

De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study

Phase 3

Withdrawn

Conditions: Liver Transplantation

Interventions: Drug: Everolimus
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Prednisolone, Prednisone or Methylprednisolone

First Posted Date: 2016-09-21

Last Posted Date: 2022-12-14

Lead Sponsor: Rennes University Hospital

Registration Number: NCT02909335

A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Phase 1

Completed

Conditions: Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma

Interventions: Biological: PDR001
Drug: QBM076
Drug: HDM201
Drug: LCL161
Drug: Everolimus
Drug: Panobinostat

First Posted Date: 2016-09-07

Last Posted Date: 2023-01-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 298

Registration Number: NCT02890069

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇬🇧
Novartis Investigative Site, Oxford, United Kingdom
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 7 locations