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 in de Novo Heart Transplant Recipients

Phase 4

Completed

Conditions: Cardiac Transplantation

Interventions: Drug: Mycophenolate mofetil + Everolimus
Drug: Everolimus

First Posted Date: 2009-11-20

Last Posted Date: 2015-01-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 182

Registration Number: NCT01017029

Locations: 🇮🇹
Novartis Investigative Site, Napoli, Italy

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

Phase 2

Completed

Conditions: Metastatic Melanoma

Interventions: Drug: Paclitaxel
Drug: Carboplatin
Drug: Everolimus

First Posted Date: 2009-11-17

Last Posted Date: 2014-03-26

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 70

Registration Number: NCT01014351

Locations: 🇺🇸
Hematology Oncology Clinic, LLP, Baton Rouge, Louisiana, United States
🇺🇸
Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
🇺🇸
Oncology Hematology of SW Indiana, Evansville, Indiana, United States

and more 9 locations

Transarterial Chemoembolization With Doxorubicin With or Without Everolimus in Treating Patients With Liver Cancer

Phase 1

Terminated

Conditions: Liver Cancer

Interventions: Drug: doxorubicin-eluting beads
Other: placebo
Drug: everolimus

First Posted Date: 2009-11-09

Last Posted Date: 2015-07-07

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 27

Registration Number: NCT01009801

Locations: 🇨🇭
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
🇨🇭
Kantonsspital - St. Gallen, St. Gallen, Switzerland
🇨🇭
Hopital Cantonal Universitaire de Geneve, Geneva, Switzerland

and more 5 locations

Everolimus on CKD Progression in ADPKD Patients

Phase 2

Terminated

Conditions: Polycystic Kidney Diseases

Interventions: Drug: Everolimus

First Posted Date: 2009-11-09

Last Posted Date: 2015-06-23

Lead Sponsor: A. Manzoni Hospital

Target Recruit Count: 71

Registration Number: NCT01009957

Locations: 🇮🇹
Modena Hospital, Modena, Italy
🇮🇹
Alessandro Manzoni Hospital, Nephrology and Dialysis Department, Lecco, Italy
🇮🇹
Dipartimento di Patologia Sistematica - Università Federico 2°, Napoli, Italy

and more 4 locations

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

Phase 3

Completed

Conditions: Metastatic Breast Cancer
HER2/Neu Over-expressing Locally Advanced Breast Cancer

Interventions: Drug: Placebo
Drug: everolimus
Drug: vinorelbine
Drug: trastuzumab

First Posted Date: 2009-11-04

Last Posted Date: 2017-04-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 569

Registration Number: NCT01007942

Locations: 🇺🇸
University of Arizona / Cancer Center AZ Onc Assoc, Tucson, Arizona, United States
🇺🇸
Florida Cancer Specialists DeptofFloridaCancerSpecialists, Fort Myers, Florida, United States
🇺🇸
Memorial Hospital Memorial Cancer Institute, Hollywood, Florida, United States

and more 41 locations

Sorafenib Tosylate With or Without Everolimus in Treating Patients With Localized, Unresectable, or Metastatic Liver Cancer

Phase 2

Completed

Conditions: Liver Cancer

Interventions: Drug: everolimus
Drug: sorafenib tosylate

First Posted Date: 2009-10-30

Last Posted Date: 2019-05-15

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 106

Registration Number: NCT01005199

Locations: 🇦🇹
Medizinische Universität Wien, Wien, Austria
🇨🇭
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona, Switzerland
🇨🇭
Saint Claraspital AG, Basel, Switzerland

and more 12 locations

Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer

Phase 2

Completed

Conditions: Esophageal Cancer
Gastric Cancer

Interventions: Drug: everolimus
Other: laboratory biomarker analysis

First Posted Date: 2009-09-28

Last Posted Date: 2020-08-05

Lead Sponsor: Translational Oncology Research International

Target Recruit Count: 49

Registration Number: NCT00985192

Locations: 🇺🇸
Antelope Valley Cancer Center, Lancaster, California, United States
🇺🇸
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
🇺🇸
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States

and more 15 locations

Sorafenib Tosylate and Everolimus in Treating Patients With Advanced Solid Tumors and Metastatic Pancreatic Cancer That Does Not Respond to Gemcitabine Hydrochloride

Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer
Recurrent Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: sorafenib tosylate
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Other: pharmacological study

First Posted Date: 2009-09-22

Last Posted Date: 2022-09-13

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 12

Registration Number: NCT00981162

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
University of Colorado at Denver Health Sciences Center, Aurora, Colorado, United States

Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma

Phase 2

Completed

Conditions: Melanoma (Skin)

Interventions: Biological: bevacizumab
Drug: carboplatin
Drug: everolimus
Drug: paclitaxel

First Posted Date: 2009-09-14

Last Posted Date: 2017-04-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 149

Registration Number: NCT00976573

Locations: 🇺🇸
Cancer Center of Kansas-Independence, Independence, Kansas, United States
🇺🇸
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
🇺🇸
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

and more 304 locations

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: everolimus

First Posted Date: 2009-09-14

Last Posted Date: 2019-08-09

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 37

Registration Number: NCT00976755

Locations: 🇨🇭
Universitaetsspital-Basel, Basel, Switzerland
🇨🇭
Kantonspital Aarau, Aarau, Switzerland
🇨🇭
Kantonsspital Baden, Baden, Switzerland

and more 9 locations

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