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.

Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.

Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

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

Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer

Phase 3

Conditions: Metastatic Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Locally Advanced Malignant Neoplasm

Interventions: Drug: Everolimus
Drug: Exemestane
Drug: Fulvestrant

First Posted Date: 2015-03-31

Last Posted Date: 2016-06-15

Lead Sponsor: Consorzio Oncotech

Target Recruit Count: 745

Registration Number: NCT02404051

Locations: 🇮🇹
Azienda Ospedaliera Policlinico di Bari, Bari, Italy
🇮🇹
A.O.R.N.A.S. Garibaldi Nesima di Catania, Catania, Italy
🇮🇹
Presidio Ospedaliero Antonio Perrino, Brindisi, Italy

and more 38 locations

Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Atypical Endometrial Hyperplasia
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Everolimus
Device: Levonorgestrel-Releasing Intrauterine System

First Posted Date: 2015-03-24

Last Posted Date: 2024-08-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 102

Registration Number: NCT02397083

Locations: 🇺🇸
Cooper Hospital University Medical Center, Camden, New Jersey, United States
🇺🇸
Queen's Medical Center, Honolulu, Hawaii, United States
🇺🇸
MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States

and more 15 locations

Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Procedure: Oral management
Drug: Everolimus

First Posted Date: 2015-03-03

Last Posted Date: 2019-10-21

Lead Sponsor: Comprehensive Support Project for Oncology Research

Target Recruit Count: 174

Registration Number: NCT02376985

Locations: 🇯🇵
Tokai University, School of Medicine, Isehara, Kanagawa, Japan

Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations

Phase 2

Completed

Conditions: Solid Malignancy
Solid Tumor

Interventions: Drug: Everolimus

First Posted Date: 2015-02-02

Last Posted Date: 2018-10-02

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 12

Registration Number: NCT02352844

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE)

Phase 4

Terminated

Conditions: Renal Cell Carcinoma

Interventions: Drug: Everolimus

First Posted Date: 2015-01-14

Last Posted Date: 2018-02-05

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 31

Registration Number: NCT02338570

Locations: 🇮🇹
Unicampus Biomedico, Roma, Italy
🇮🇹
AOU San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy
🇮🇹
Casa di Cura La Maddalena, Palermo, Italy

and more 5 locations

Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus

Phase 4

Completed

Conditions: Growth and Development

Interventions: Drug: Everolimus

First Posted Date: 2015-01-14

Last Posted Date: 2024-08-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 15

Registration Number: NCT02338609

Locations: 🇺🇸
Cinn Children Hosp Medical Center SC, Cincinnati, Ohio, United States
🇷🇺
Novartis Investigative Site, Moscow, Russian Federation
🇺🇸
University Of California LA SC, Los Angeles, California, United States

and more 2 locations

Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Phase 3

Completed

Conditions: Chronic Kidney Disease

Interventions: Drug: Everolimus
Drug: Tacrolimus
Drug: Mycophenolate sodium

First Posted Date: 2015-01-08

Last Posted Date: 2021-01-29

Lead Sponsor: Poitiers University Hospital

Target Recruit Count: 329

Registration Number: NCT02334488

Locations: 🇫🇷
Angers University Hospital, Angers, France
🇫🇷
Poitiers University Hospital, Poitiers, France
🇫🇷
Reims University Hospital, Reims, France

and more 11 locations