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

Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer

Phase 2

Terminated

Conditions: Birt-Hogg-Dube Syndrome
Renal Cancer

Interventions: Drug: Everolimus

First Posted Date: 2015-07-22

Last Posted Date: 2019-03-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 3

Registration Number: NCT02504892

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study

Phase 4

Conditions: Left Ventricular Hypertrophy

Interventions: Drug: Everolimus

First Posted Date: 2015-07-09

Last Posted Date: 2015-07-09

Lead Sponsor: Instituto de Urologia e Nefrologia

Target Recruit Count: 50

Registration Number: NCT02493465

Locations: 🇧🇷
Instituto de Urologia e Nefrologia, São José do Rio Preto, São Paulo, Brazil

Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative

Phase 2

Completed

Conditions: Triple-Negative Breast Carcinoma
Invasive Breast Carcinoma

Interventions: Biological: Bevacizumab
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Drug: Pegylated Liposomal Doxorubicin Hydrochloride

First Posted Date: 2015-05-29

Last Posted Date: 2024-02-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 17

Registration Number: NCT02456857

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Phase 1

Completed

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Lenvatinib
Drug: Everolimus

First Posted Date: 2015-05-27

Last Posted Date: 2019-03-19

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 7

Registration Number: NCT02454478

Locations: 🇯🇵
Eisai Trial Site #1, Tokyo, Japan
🇯🇵
Eisai Trial Site #2, Tokyo, Japan

A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD

Phase 2

Completed

Conditions: Tuberous Sclerosis Complex
Epilepsy
Focal Cortical Dysplasia

Interventions: Drug: Everolimus

First Posted Date: 2015-05-22

Last Posted Date: 2021-09-01

Lead Sponsor: NYU Langone Health

Target Recruit Count: 15

Registration Number: NCT02451696

Locations: 🇺🇸
New York University Langone Medical Center, New York, New York, United States

Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Not Applicable

Conditions: Neoplasm

Interventions: Drug: Everolimus
Drug: Letrozole

First Posted Date: 2015-05-21

Last Posted Date: 2015-05-21

Lead Sponsor: Sinai Hospital of Baltimore

Target Recruit Count: 50

Registration Number: NCT02450175

Locations: 🇺🇸
SInai Hospital of Baltimore, Inc., Baltimore, Maryland, United States

Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Phase 2

Completed

Conditions: Solid Tumor

Interventions: Drug: everolimus

First Posted Date: 2015-05-20

Last Posted Date: 2017-02-17

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 10

Registration Number: NCT02449538

Locations: 🇰🇷
Samsung Medical center, Seoul, Korea, Republic of

Safety and Durability of Sirolimus for Treatment of LAM

Recruiting

Conditions: Lymphangioleiomyomatosis

Interventions: Drug: Sirolimus
Drug: Everolimus

First Posted Date: 2015-05-04

Last Posted Date: 2024-05-16

Lead Sponsor: University of Cincinnati

Target Recruit Count: 600

Registration Number: NCT02432560

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Stanford University Medical Center, Stanford, California, United States

and more 17 locations

Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

Phase 4

Completed

Conditions: Kidney Transplant
HIV
Liver Transplant

Interventions: Drug: everolimus

First Posted Date: 2015-04-29

Last Posted Date: 2019-11-19

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 10

Registration Number: NCT02429869

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Phase I Trial of VS-6766 Alone and in Combination With Everolimus

Phase 1

Recruiting

Conditions: Lung Cancer
Solid Tumours
Ovarian Cancer
Multiple Myeloma

Interventions: Drug: VS-6766
Drug: Everolimus

First Posted Date: 2015-04-03

Last Posted Date: 2024-03-21

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 104

Registration Number: NCT02407509

Locations: 🇬🇧
Guy's and St Thomas' Hospital, London, United Kingdom
🇬🇧
Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
🇬🇧
Gynaecological Unit - Royal Marsden NHS Foundation Trust, London, United Kingdom

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy