- |||||||||| everolimus / Generic mfg., sorafenib / Generic mfg.
Trial completion date, Trial primary completion date: Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas (clinicaltrials.gov) - Jul 15, 2019 P1/2, N=118, Recruiting, Trial completion date: Jul 2020 --> Dec 2021 | Trial primary completion date: Jul 2019 --> Dec 2020
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Everolimus for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC). (Pubmed Central) - Jul 13, 2019 Areas covered: We comprehensively reviewed the evidence from preclinical and phase I and II clinical trials, based on the authors'clinical experience and a pubmed, Chochrane library, Embase, and Google Scholar search everolimus + pancreatic cancer. Expert opinion: Everolimus has not demonstrated efficacy in PDAC; however, an mTOR inhibitor in combination with stroma-targeted therapies may be a promising area to explore in clinical trials.
- |||||||||| ganaxolone oral (CCD-1042) / Marinus, Afinitor (everolimus) / Novartis
Clinical, Journal: Antiepileptic drugs in clinical development: differentiate or die? (Pubmed Central) - Jul 11, 2019 Substantial improvements in the efficacy, specifically as pharmacological treatment of drug-resistant epilepsy is regarded, are not expected. New drugs should be developed to specifically target the biochemical alteration which characterizes the underlying disease and also include targets that contribute to epileptogenesis in relevant epilepsy models.
- |||||||||| cisplatin / Generic mfg., everolimus / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: Cisplatinum and Everolimus in Patients With Metastatic or Unresectable NEC of Extrapulmonary Origin (clinicaltrials.gov) - Jul 11, 2019 P2, N=39, Recruiting, Oblate wrapping prevented recurrence of grade 2 or more stomatitis in patients who took uncovered everolimus and developed significant stomatitis. Trial completion date: Jan 2019 --> Jun 2021 | Trial primary completion date: Jan 2019 --> Jun 2020
- |||||||||| xentuzumab (BI-836845) / Boehringer Ingelheim
Trial completion date, Trial primary completion date, Combination therapy, Metastases: The XENERA (clinicaltrials.gov) - Jul 9, 2019 P2, N=80, Recruiting, Trial completion date: Jan 2019 --> Jun 2021 | Trial primary completion date: Jan 2019 --> Jun 2020 Trial completion date: Jan 2022 --> Jul 2022 | Trial primary completion date: Dec 2020 --> May 2021
- |||||||||| veliparib (ABT-888) / AbbVie, Mekinist (trametinib) / Novartis, BeiGene, adavosertib (AZD1775) / AstraZeneca
Trial primary completion date, Metastases: MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations (clinicaltrials.gov) - Jul 9, 2019 P2, N=700, Recruiting, Trial completion date: Jan 2022 --> Jul 2022 | Trial primary completion date: Dec 2020 --> May 2021 Trial primary completion date: May 2019 --> May 2020
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, P2 data, Review, Journal, IO Biomarker: A Systematic Review of Phase II Targeted Therapy Clinical Trials in Anaplastic Thyroid Cancer. (Pubmed Central) - Jul 7, 2019 These studies underscore the importance of molecular profiling of tumors for appropriate patient selection and determination of genomic correlates of response. Clinical trials are underway testing additional targeted therapies as monotherapy, or as a part of multimodal treatment, and in combination with immunotherapy.
- |||||||||| Afinitor (everolimus) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, HEOR: Nivolumab in the Treatment of Metastatic Renal Cell Carcinoma: A Cost-Utility Analysis. (Pubmed Central) - Jul 7, 2019 Compared with everolimus, nivolumab is unlikely to be cost-effective for the treatment of mRCC from a Canadian health care perspective with its current price assuming a WTP of $50,000/QALY. Although mRCC patients derive a meaningful clinical benefit from nivolumab, considerations should be given to avoid drug wastage and increase the WTP threshold to render this strategy more affordable.
- |||||||||| Afinitor (everolimus) / Novartis
Review, Journal: Systemic treatment for lung carcinoids: from bench to bedside. (Pubmed Central) - Jul 6, 2019 ...Systemic therapy represents the main option in advanced and unresectable disease; accepted choices are somatostatin analogs, peptide receptor radionuclide therapy, everolimus and chemotherapy...Further studies are necessary to identify new potential "druggable" molecular targets in the selected subset of low-grade lung carcinoids. Furthermore, evaluating the available therapies in more homogeneous population might improve their efficacy through a perfect tailoring of treatment options.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: The SR-B1 Receptor as a Potential Target for Treating Glioblastoma. (Pubmed Central) - Jul 6, 2019 ...These studies involve the evaluation of reconstituted high density lipoprotein (rHDL) nanoparticles (NPs) as delivery agents for the drug, mammalian Target of Rapamycin (mTOR) inhibitor Everolimus (EVR) to GBM cells...These studies present strong proof of concept regarding the efficacy of delivering EVR and likely other agents, via a biocompatible transport system, targeted to the SR-B1 receptor that is upregulated in most cancers, including GBM. Targeting the SR-B1 receptor could thus lead to effective personalized therapy of GBM.
- |||||||||| everolimus / Generic mfg., sorafenib / Generic mfg.
Trial completion date, Trial primary completion date: Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer (clinicaltrials.gov) - Jul 5, 2019 P2, N=41, Active, not recruiting, Targeting the SR-B1 receptor could thus lead to effective personalized therapy of GBM. Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| Campath (alemtuzumab) / Sanofi, Afinitor (everolimus) / Novartis
Clinical, Journal: Testicular Cancer in a Lung Transplant Patient With Cystic Fibrosis: A Case Report. (Pubmed Central) - Jun 28, 2019 Immunosuppressive treatment was changed to tacrolimus, everolimus, and prednisolone, which did not influence excellent graft function. This case report highlights the importance of uro-oncological observation of patients with CF following lung transplantations.
- |||||||||| Sutent (sunitinib) / Pfizer
Trial completion, Trial completion date, Trial primary completion date, Metastases: Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors (clinicaltrials.gov) - Jun 25, 2019 P=N/A, N=25, Completed, In our study, the median PFS was borderline significantly different between hospital types, possibly the result of a different assessment approach in the first 12-week treatment period. Recruiting --> Completed | Trial completion date: May 2020 --> Jun 2019 | Trial primary completion date: May 2020 --> Jun 2019
- |||||||||| Sutent (sunitinib) / Pfizer
Trial completion date, Trial primary completion date, Real-world evidence, Real-world, Metastases: OPALINE : A Study Of Morbidity And Mortality At 2 Years (clinicaltrials.gov) - Jun 20, 2019 P=N/A, N=150, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Jun 2019 --> Sep 2019 | Trial primary completion date: Jun 2019 --> Sep 2019
- |||||||||| Afinitor (everolimus) / Novartis
Retrospective data, Journal: Genomically annotated risk model for advanced renal-cell carcinoma: a retrospective cohort study. (Pubmed Central) - Jun 19, 2019 The mutation status of BAP1, PBRM1, and TP53 has independent prognostic value in patients with advanced or metastatic renal-cell carcinoma treated with first-line tyrosine kinase inhibitors. Improved stratification of patients across risk groups by use of a genomically annotated model including the mutational status of these three genes warrants further investigation in prospective trials and could be of use as a model to stratify patients with metastatic renal-cell carcinoma in clinical trials.
- |||||||||| Afinitor (everolimus) / Novartis
Biomarker, PK/PD data, Journal: Pharmacodynamic Monitoring of mTOR Inhibitors. (Pubmed Central) - Jun 19, 2019 Although limited, the available data on mTOR pathway biomarkers seem promising. Before clinical implementation, the analytical methodologies must be standardized and cross-validated, and the selected biomarkers will have to demonstrate their clinical utility for SRL or EVR dose individualization in multicenter clinical trials.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: The role of GSK3 and its reversal with GSK3 antagonism in everolimus resistance. (Pubmed Central) - Jun 17, 2019 The combination of everolimus with the PI3Kα inhibitor BYL719 re-established everolimus sensitivity through GSK3 inhibition and restoration of autophagy. We suggest that GSK3 over-activation combined with decreased basal IRS-1 protein levels and decreased autophagy may be a crucial feature of everolimus resistance, and hence a possible therapeutic target.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: The immune system as a chronotoxicity target of the anticancer mTOR inhibitor everolimus. (Pubmed Central) - Jun 15, 2019 The mean circulating counts in total leukocytes, total lymphocytes, T-helper and B lymphocytes displayed minor and non-significant changes following dosing at ZT13, while they were decreased by 56.9% (p < 0.01), 45.5% (p < 0.01), 43.1% (p < 0.05) and 48.7% (p < 0.01) after everolimus at ZT1, respectively, in only male mice. Chronotherapy of everolimus is an effective way to increase the general tolerability and decrease toxicity on the immune system.
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