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Everolimus - ClinicalTrials.gov

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Last Updated: 07 August 2022

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Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

In patients with bronchial neuroendocrine tumor, the progression-free survival of getting lutetium Lu 177 dotatate is compared to that of receiving everolimus in patients with bronchial neuroendocrine tumors. In patients with bronchial NET, we'll compare the overall survival of receiving lutetium Lu 177 dotatate versus everolimus. In patients with bronchial NET, we will compare the overall response rate between lutetium Lu 177 dotatate and everolimus. To assess and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus. ARM I: On day 1 of each cycle, patients receive lutetium Lu 177 dotatate intravenously for 30-40 minutes. ARM II: Patients receive everolimus orally twice a day on days 1-28 of each cycle. Patients with disease progression may be able to cross over to Arm I. Patients are followed every 3 months until disease progression, then every 6 months after study enrollment, and then every 6 months for up to five years after publication.

Source link: https://clinicaltrials.gov/ct2/show/NCT04665739


Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

l. To determine the survival rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab. To determine the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel therapies, we'll take a look at the following table. To determine the overall biochemical response rate in patients with metastatic pancreatic neuroendocrine tumors treated with these drugs, we can determine the overall biochemical response rate in patients with these regimens. As in Arms I, patients are given everolimus and octreotide acetate. Patients in the hospital also received bevacizumab intravenously over 30-90 minutes on days 1 and 15.

Source link: https://clinicaltrials.gov/ct2/show/NCT01229943


Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma

In ten patients with confirmed TSC-AML diagnosis and who meet the local reimbursement guidelines for TSC-AML therapy, this open-label, prospective, single-arm multicenter study is scheduled to be conducted. Patients who are continuing to be on medical therapy beyond 52 weeks, according to the investigator's decision, will not be included in the 13-week safety follow-up period.

Source link: https://clinicaltrials.gov/ct2/show/NCT05252585


Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment)

In terms of overall severity of mIAS-associated pain, it will be more effective compared to placebo's introduction of dexamethasone at the start of everolimus therapy. When dexamethasone mouth rinse use starts at the same time as everolimus use begins, it's easier to determine whether quality of life is better. Starting dexamethasone mouth rinse concurrently with the introduction of everolimus therapy may help patients' ability to adhere to everolimus therapy. At the beginning of everolimus, it was necessary to determine dexamethasone prescription fill rates and times between patients who were placebo versus study drug. Patients are given everolimus orally once a day as a standard of care and dexamethasone as mouthwash over 2 minutes 4 times per day for eight weeks.

Source link: https://clinicaltrials.gov/ct2/show/NCT03839940


AERO: Adjuvant EveRolimus Outcomes in Laryngotracheal Stenosis

Everolimus will be tested in subsequent larger trials of participants with laryngotracheal stenosis, and may lead to everolimus being the first FDA-approved medical therapy for iSGS.

Source link: https://clinicaltrials.gov/ct2/show/NCT05153668


EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study

OBJECTIVES: After nephrectomy or partial nephrectomy, primary to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Secondary To determine the overall survival of patients treated with everolimus vs placebo, we'll compare the results from the trial. Bank tissue and biologic samples are needed for future research of molecular biomarkers important to renal carcinoma formation and dissemination of their potential predictive and prognostic value. This study used troughly trough levels of everolimus and important side effects in patients treated with everolimus. Arm I: Patients are on days 1-42 when they receive oral everolimus once a day. Patients are expected to receive oral placebo once a day on days 1-42. Arm II: Patients receive oral placebo once daily on days 1-42. Periodic tumor tissue, plasma, and whole blood samples can be obtained periodically for biomarker analysis and other translational studies.

Source link: https://clinicaltrials.gov/ct2/show/NCT01120249


A Randomized Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DES for Percutaneous Coronary Intervention in Patients With Diabetes Mellitus: an Investigator-initiated Pilot Study

This trial comparing Abluminus DES+ and eluting DES on diabetic patients undergoing Percutaneous Coronary Intervention is aimed at a prospective, multicentre, national, randomized, open label, 2-arm parallel group, pilot trial, pilot trial, with a prospective, multicentre, multi-arm parallel group, pilot trial comparing Abluminus DES+ versus Everolimus-eluting DES on Late Lumen Loss Patients will be followed up by an angiographic follow-up at 9 months and a clinical follow-up at 12 months following the index procedure. However, the members of the Event Adjuddication Committee will be blinded to the patient. The adjudication process's medical records, source documentation, and event data collected for the adjudication process will be blinded to treatment assignment.

Source link: https://clinicaltrials.gov/ct2/show/NCT03399994


Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Primary To determine whether or not the addition of one year of everolimus to standard adjuvant endocrine therapy improves invasive disease-free survival in patients with high-risk, hormone-positive, and human epidermal growth factor receptor 2-negative breast cancer patients. In this patient population, we want to investigate the effectiveness, toxicities, and tolerateability of one year of everolimus in combination with standard adjuvant endocrine therapy in order to compare it to standard adjuvant endocrine therapy plus placebo. To determine whether or not the benefit of one year of everolimus use in comparison to standard adjuvant endocrine therapy differs according to recurrence score, nodal status, or other commonly used prognostic factors. In arm II, patients receive an approved endocrine therapy regimen. In the absence of disease progression or unacceptable toxicity, patients are also receiving everolimus PO daily for 1 year. IMPORTANT INFO: Note: *Men receive a tamoxifen citrate PO for 5 years.

Source link: https://clinicaltrials.gov/ct2/show/NCT01674140

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions