Everolimus
- Generic Name
- Everolimus
- Brand Names
- Afinitor, Votubia, Zortress
- Drug Type
- Small Molecule
- Chemical Formula
- C53H83NO14
- 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
- -
Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
- Conditions
- Hepatosplenic T-cell LymphomaRecurrent Mantle Cell LymphomaSplenic Marginal Zone LymphomaAnaplastic Large Cell LymphomaPeripheral T-cell LymphomaRecurrent Grade 2 Follicular LymphomaWaldenstrom MacroglobulinemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueRecurrent Adult Burkitt LymphomaRecurrent Mycosis Fungoides/Sezary Syndrome
- Interventions
- First Posted Date
- 2010-02-25
- Last Posted Date
- 2020-10-22
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 58
- Registration Number
- NCT01075321
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)
- First Posted Date
- 2010-02-18
- Last Posted Date
- 2017-03-13
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Target Recruit Count
- 20
- Registration Number
- NCT01070316
- Locations
- 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸Baylor College of Medicine, Houston, Texas, United States
A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis
- First Posted Date
- 2010-01-29
- Last Posted Date
- 2020-11-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 24
- Registration Number
- NCT01059318
- Locations
- 🇺🇸
Center for LAM Research and Clinical Care, Boston, Massachusetts, United States
🇮🇹Novartis Investigative Site, Milan, Italy
🇺🇸University of Cincinnati, Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine,, Cincinnati, Ohio, United States
RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer
- First Posted Date
- 2010-01-29
- Last Posted Date
- 2017-04-13
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 56
- Registration Number
- NCT01058655
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Everolimus Rescue Immunosuppression in the Treatment of Chronic Allograft Dysfunction in Renal Transplant Recipients
- Conditions
- Interventions
- First Posted Date
- 2010-01-11
- Last Posted Date
- 2015-06-22
- Lead Sponsor
- Chinese University of Hong Kong
- Target Recruit Count
- 17
- Registration Number
- NCT01046045
- Locations
- 🇭🇰
Prince of Wales Hospital, Hong Kong, Hong Kong
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
- Conditions
- Interventions
- First Posted Date
- 2009-12-18
- Last Posted Date
- 2016-09-22
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 546
- Registration Number
- NCT01035229
- Locations
- 🇹🇭
Novartis Investigative Site, Bangkok, Thailand
🇺🇸University of California San Diego - Moores Cancer Center SC - 3, La Jolla, California, United States
🇺🇸Compassionate Cancer Care Medical Group CCCMG, Fountain Valley, California, United States
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
- First Posted Date
- 2009-12-17
- Last Posted Date
- 2022-07-11
- Lead Sponsor
- Hoosier Cancer Research Network
- Target Recruit Count
- 154
- Registration Number
- NCT01034631
- Locations
- 🇦🇺
Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇺🇸Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
🇺🇸Northwest Alabama Cancer Center, Muscle Shoals, Alabama, United States
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2009-12-14
- Last Posted Date
- 2018-08-31
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- Target Recruit Count
- 55
- Registration Number
- NCT01031446
- Locations
- 🇺🇸
Erlanger Cancer Center at Erlanger Hospital - Baroness, Chattanooga, Tennessee, United States
🇺🇸West Tennessee Cancer Center at Jackson-Madison County General Hospital, Jackson, Tennessee, United States
🇺🇸Baptist Regional Cancer Center at Baptist Riverside, Knoxville, Tennessee, United States
Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity
- First Posted Date
- 2009-12-03
- Last Posted Date
- 2015-05-12
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 11
- Registration Number
- NCT01024946
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
- Conditions
- Interventions
- First Posted Date
- 2009-12-02
- Last Posted Date
- 2016-07-19
- Lead Sponsor
- Novartis
- Target Recruit Count
- 330
- Registration Number
- NCT01023815
- Locations
- 🇮🇹
Novartis Investigative Site, Vicenza, Italy
🇮🇹Novartis InvestigativeSite, Udine, Italy
🇮🇹Novarits Investigative Site, Pisa, Italy
Drug Development Updates
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