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

Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

First Posted Date: 2015-12-23

Last Posted Date: 2020-03-19

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 90

Registration Number: NCT02638428

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

Safety and Tolerability of Everolimus in Combination With Eribulin in Triple-negative Breast Cancers

Phase 1

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Everolimus
Drug: Eribulin

First Posted Date: 2015-11-30

Last Posted Date: 2015-11-30

Lead Sponsor: Istituti Ospitalieri di Cremona

Target Recruit Count: 1

Registration Number: NCT02616848

Locations: 🇮🇹
AO Cremona, Cremona, Lombardia, Italy

Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

Phase 1

Completed

Conditions: Metastatic Renal Cell Carcinoma
Advanced Gastric Adenocarcinoma
Advanced Urothelial Carcinoma
Metastatic Colorectal Adenocarcinoma

Interventions: Drug: ibrutinib
Drug: everolimus
Drug: docetaxel
Drug: paclitaxel
Drug: pembrolizumab
Drug: cetuximab

First Posted Date: 2015-11-06

Last Posted Date: 2023-11-18

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 263

Registration Number: NCT02599324

Locations: 🇺🇸
Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411, Norwalk, Connecticut, United States
🇬🇧
Sarah Cannon Research Institute /ID# 1128-1079, London, England, United Kingdom
🇺🇸
Franciscan Health Indianapolis /ID# 1128-1125, Indianapolis, Indiana, United States

and more 62 locations

Study of the Combination of CM082 With Everolimus in Patients With mRCC

Phase 1

Conditions: Renal Cell Carcinoma Recurrent

Interventions: Drug: CM082
Drug: Everolimus

First Posted Date: 2015-10-16

Last Posted Date: 2018-01-10

Lead Sponsor: AnewPharma

Target Recruit Count: 18

Registration Number: NCT02577458

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

Open Label Study of Everolimus (RAD001) in Patients With Segmental Overgrowth Syndrome

Phase 2

Withdrawn

Conditions: Segmental Overgrowth Syndrome

Interventions: Drug: Everolimus

First Posted Date: 2015-10-06

Last Posted Date: 2017-09-28

Lead Sponsor: Jochen Roessler

Registration Number: NCT02569125

Locations: 🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany
🇩🇪
Vivantes Klinikum Neukölln, Berlin, Germany
🇩🇪
Universitätsklinikum Leipzig, Leipzig, Germany

and more 1 locations

Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

Phase 2

Terminated

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Sunitinib
Drug: Temsirolimus
Drug: Sorafenib
Drug: Pazopanib
Drug: Everolimus
Drug: Axitinib

First Posted Date: 2015-09-25

Last Posted Date: 2018-10-12

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 4

Registration Number: NCT02560012

Locations: 🇺🇸
UTHealth Memorial Hermann Cancer Center, Houston, Texas, United States

Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus

Phase 2

Terminated

Conditions: Sporadic Angiomyolipomas (AMLs)

Interventions: Drug: Everolimus

First Posted Date: 2015-09-03

Last Posted Date: 2022-12-15

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 20

Registration Number: NCT02539459

Locations: 🇺🇸
Yale School of Medicine, New Haven, Connecticut, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 5 locations

Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Carboplatin
Drug: Everolimus

First Posted Date: 2015-08-25

Last Posted Date: 2024-02-20

Lead Sponsor: amy tiersten

Target Recruit Count: 62

Registration Number: NCT02531932

Locations: 🇺🇸
Mount Sinai Downtown, New York, New York, United States
🇺🇸
Mount Sinai West, New York, New York, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Letrozole
Drug: Everolimus
Drug: TRC105

First Posted Date: 2015-08-11

Last Posted Date: 2023-12-29

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 15

Registration Number: NCT02520063

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients

Phase 3

Completed

Conditions: Breast Cancer Metastatic

Interventions: Drug: Everolimus
Drug: Aromatase Inhibitors

First Posted Date: 2015-07-30

Last Posted Date: 2020-12-03

Lead Sponsor: Istituto Oncologico Veneto IRCCS

Target Recruit Count: 110

Registration Number: NCT02511639

Locations: 🇮🇹
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, AN, Italy
🇮🇹
ASL Brindisi "Antonio Perrini", Brindisi, BR, Italy
🇮🇹
Ospedale Papa Giovanni XXIII, Bergamo, Bg, Italy

and more 13 locations

Drug Development Updates

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

Home Terms & Conditions Privacy Policy