Clinical Trials Using Everolimus

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Everolimus. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 51
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  • Hormone Therapy with or without Everolimus in Treating Patients with Breast Cancer

    This randomized phase III trial studies how well hormone therapy when given together with or without everolimus work in treating patients with breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
    Location: 1296 locations

  • Sorafenib Tosylate with or without Everolimus in Treating Patients with Advanced, Radioactive Iodine Refractory Thyroid Cancer

    This randomized phase II trial studies the effects, good and bad, of using everolimus along with sorafenib tosylate versus sorafenib tosylate alone in treating patients with thyroid cancer that has spread to other places in the body or cannot be removed by surgery and has not responded to treatment with radioactive iodine. Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of everolimus to sorafenib tosylate may cause more shrinkage of thyroid cancer and may prevent it from growing but it could also cause more side effects than sorafenib tosylate alone. It is not yet known whether this treatment with sorafenib tosylate and everolimus is better, the same, or worse than sorafenib tosylate alone.
    Location: 19 locations

  • A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

    The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
    Location: 16 locations

  • Everolimus in Treating Younger Patients with Recurrent or Progressive Low-Grade Gliomas

    This phase II trial studies how well everolimus works in treating younger patients with recurrent or progressive low-grade gliomas. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 15 locations

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

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.
    Location: 8 locations

  • Everolimus in Treating Patients with Sporadic Angiomyolipomas

    This phase II trial studies how well everolimus works in treating patients with sporadic angiomyolipomas, common non-cancerous kidney tumors composed of blood vessels, muscle cells, and fat cells. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and blocking the growth of new blood vessels necessary for tumor growth.
    Location: 8 locations

  • Levonorgestrel-Releasing Intrauterine System with or without Everolimus in Treating Patients with Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer

    This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.
    Location: 8 locations

  • Lenvatinib / Everolimus or Lenvatinib / Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

    This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.
    Location: 7 locations

  • Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced / Metastatic Breast Cancer Post Progression on CDK 4 / 6 Inhibitor.

    The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is effective in the treatment of locally advanced / metastatic breast cancer following treatment with a CDK 4 / 6 inhibitor
    Location: 6 locations

  • A Phase 2 Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease

    This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus in participants with unresectable advanced or metastatic non clear cell renal cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. The primary objective of the study is to evaluate the objective response rate (ORR). This study consists of three phases: a Pretreatment Phase (Screening and Baseline Periods), a Treatment Phase (starting Cycle 1, Day 1), and a Posttreatment Phase (End of Treatment Visit and survival Follow-up).
    Location: 5 locations

  • Study of Radium-223 Dichloride Versus Placebo and Treatment With Exemestane / Everolimus in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

    The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus.
    Location: 5 locations

  • Everolimus, Letrozole, and Trastuzumab in Treating Patients with Hormone Receptor-Positive and HER2-Positive Advanced Metastatic Breast Cancer or Other Solid Tumors

    This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2 (HER2)-positive breast cancer or other solid tumors that have spread to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells. Monoclonal antibodies, such as trastuzumab, may find tumor cells and help kill them. Giving everolimus, letrozole, and trastuzumab together may be a better treatment for breast cancer and other solid tumors.
    Location: 5 locations

  • Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

    Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors. This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and / or refractory solid tumors to receive CB-839 capsules orally twice or three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors. As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.
    Location: 5 locations

  • Palbociclib, Everolimus, and Exemestane in Treating Patients with Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer

    This phase Ib / IIa trial studies the side effects and best dose of palbociclib and everolimus and how well they work when given together with exemestane in treating patients with estrogen receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer that has spread to other places in the body. Palbociclib, everolimus, and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Carboplatin with or without Everolimus in Treating Patients with Metastatic Triple Negative Breast Cancer

    This randomized phase II trial studies carboplatin with or without everolimus in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as carboplatin and everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 3 locations

  • Everolimus in Treating Patients with TSC1, TSC2, or Activating MTOR Mutated Cancer That Is Metastatic, Recurrent, or Cannot Be Removed by Surgery

    This phase II trial studies how well everolimus works in treating patients with tuberous sclerosis complex (TSC)1, TSC2, or activating mammalian target of rapamycin (MTOR) mutated cancer that has spread to other parts of the body (metastatic), has come back (recurrent), or cannot be removed by surgery. Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer

    The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg / m^2 / day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).
    Location: 3 locations

  • Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer

    This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid / Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
    Location: 4 locations

  • Everolimus in Treating Younger Patients With Neurofibromatosis Type 1 or Low Grade Gliomas That Did Not Responded to Chemotherapy

    RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well everolimus works in treating younger patients with neurofibromatosis type 1 or low grade gliomas that did not respond to chemotherapy.
    Location: 3 locations

  • Ribociclib and Everolimus in Treating Children with Recurrent or Refractory Malignant Brain Tumors

    This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and everolimus may work better at treating malignant brain tumors.
    Location: 2 locations

  • Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma

    Study E7080-G000-218 is a Randomized, Double-blind, Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any ≥ Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
    Location: 2 locations

  • Ribociclib and Everolimus in Treating Patients with Locally Advanced, Metastatic, or Refractory Dedifferentiated Liposarcoma or Leiomyosarcoma

    This phase II clinical trial studies how well ribociclib and everolimus work in treating patients with dedifferentiated liposarcoma or leiomyosarcoma that has spread to nearby tissue or to other places in the body or has not responded to treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Ribociclib and Everolimus in Treating Patients with Advanced Well Differentiated Neuroendocrine Tumors of Foregut Origin

    This phase II trial studies how well ribociclib and everolimus work in treating patients with well differentiated neuroendocrine tumors of foregut origin that have spread to other parts of the body and usually cannot be cured or controlled with treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • Mutation-Targeted Therapy with Sunitinib Malate or Everolimus in Treating Patients with Advanced Neuroendocrine Tumors of the Gastrointestinal Tract or Pancreas

    This pilot phase II trial studies how well mutation (changes in deoxyribonucleic acid [DNA])-targeted therapy with sunitinib malate or everolimus work in treating patients with neuroendocrine tumors of the gastrointestinal tract or pancreas that have spread to other places in the body and usually cannot be cured or controlled with treatment. Mutation-targeted therapy is a type of treatment that uses drugs, such as sunitinib malate or everolimus, to identify and attack specific types of tumor cells that may have less harm to normal cells. Sunitinib malate or everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Everolimus in Treating Children with Recurrent or Refractory Ependymoma or Anaplastic Ependymoma

    This phase II trial studies the side effects of everolimus and to see how well it works in treating children with ependymoma or anaplastic ependymoma that has come back or has not responded to previous treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations


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