- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial primary completion date: RAD001 and Neurocognition in PTEN Hamartoma Tumor Syndrome (clinicaltrials.gov) - May 15, 2019
P1/2, N=40, Recruiting,
Trial completion date: Jun 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| letrozole / Generic mfg., everolimus / Generic mfg.
Enrollment closed, Trial completion date, Metastases: PerELISA: Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients (clinicaltrials.gov) - May 14, 2019
P1, N=42, Active, not recruiting,
Trial completion date: Jun 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020 Recruiting --> Active, not recruiting | Trial completion date: Jul 2019 --> Jul 2020
- |||||||||| darTregs / National Institute of Allergy and Infectious Diseases
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: deLTa: Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (clinicaltrials.gov) - May 13, 2019
P1, N=15, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jul 2019 --> Jul 2020 Recruiting --> Active, not recruiting | N=24 --> 15 | Trial completion date: Jan 2022 --> Jun 2019 | Trial primary completion date: Jan 2022 --> Jun 2019
- |||||||||| Enrollment change, Trial primary completion date: Efficacy and Safety of Precision Therapy in Refractory Tumor (clinicaltrials.gov) - May 10, 2019
P2, N=300, Recruiting,
(Received April 19, 2018; Accepted August 9, 2018; Published November 1, 2018). N=60 --> 300 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| Afinitor (everolimus) / Novartis
Review, Journal: mTOR Inhibitors in Advanced Biliary Tract Cancers. (Pubmed Central) - May 9, 2019
Rapalogs in clinical trials demonstrate some activity in patients with advanced BTC. New-generation mTOR inhibitors against ATP-binding pocket inhibit both TORC1 and TORC2 and demonstrate more potent anti-tumor effects in vitro and in vivo, however, prospective clinical trials are warranted to prove its efficacy in patients with advanced BTC.
- |||||||||| everolimus / Generic mfg.
Trial primary completion date: NFC-RAD001: Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas (clinicaltrials.gov) - May 9, 2019
P2, N=23, Active, not recruiting,
New-generation mTOR inhibitors against ATP-binding pocket inhibit both TORC1 and TORC2 and demonstrate more potent anti-tumor effects in vitro and in vivo, however, prospective clinical trials are warranted to prove its efficacy in patients with advanced BTC. Trial primary completion date: Apr 2019 --> Dec 2019
- |||||||||| Trial completion, Trial completion date, Trial primary completion date, Surgery, Metastases: Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus (clinicaltrials.gov) - May 7, 2019
P2, N=61, Completed,
Everolimus enhances features of plaque stability and counters cardiovascular complications in ApoEFbn1 mice, even when administered at a later stage of the disease. Active, not recruiting --> Completed | Trial completion date: Apr 2020 --> Nov 2018 | Trial primary completion date: Apr 2019 --> Nov 2018
- |||||||||| Afinitor (everolimus) / Novartis
Preclinical, Journal: Dynamics of PI3K and Hippo signaling pathways during in vitro human follicle activation. (Pubmed Central) - May 5, 2019
...One hundred and twelve frozen-thawed ovarian cortex fragments from four patients were exposed to dimethylsulfoxide (DMSO-control group), everolimus (inhibitor group) or bpV (HOpic) and 740Y-P (activators group) during the first 24 and 48 h, respectively, and cultured for additional 5 days...7.6516.16 F and 7.4578.14 F) and the Fonds Erasme. No competing interests declared.
- |||||||||| Afinitor (everolimus) / Novartis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Review, Journal, Adverse events: Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. (Pubmed Central) - May 5, 2019
We discuss the potential mechanisms underlying these AEs and present practical recommendations for managing toxicities. The development of treatment plans that include prophylactic and therapeutic strategies for the management of lenvatinib-associated AEs has the potential to improve patient quality of life, optimize adherence, minimize the need for dose reductions, treatment interruptions, or discontinuations, and maximize patient outcomes.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: An occult urothelial carcinoma with wide multiorgan metastases and its genetic alteration profiling: Case report and literature review. (Pubmed Central) - May 5, 2019
The development of treatment plans that include prophylactic and therapeutic strategies for the management of lenvatinib-associated AEs has the potential to improve patient quality of life, optimize adherence, minimize the need for dose reductions, treatment interruptions, or discontinuations, and maximize patient outcomes. In this initial report of occult urothelial carcinoma, we obtained information on genetic variations of tumor tissue which could provide important information for subsequent studies on this kind of disease.
- |||||||||| everolimus / Generic mfg.
Biomarker, Review, Journal: Gastroenteropancreatic Neuroendocrine Tumors. (Pubmed Central) - Apr 30, 2019
Chemotherapy with temozolomide and capecitabine has recently demonstrated an unprecedented prolongation of progression-free survival in a randomized trial of pNETs...Telotristat, an oral inhibitor of tryptophan hydroxylase, has been shown to reduce diarrhea in patients with carcinoid syndrome. Defining the therapeutic algorithm and identifying biomarkers predictive of response to treatments are among the main priorities for the next decade of research in the NET field.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: A case report on metastatic ileal neuroendocrine neoplasm to the breast masquerading as primary breast cancer: A diagnostic challenge and management dilemma. (Pubmed Central) - Apr 30, 2019
Based on a wealth of validating preclinical studies, we contend that the favorable metabolic effects of mineralocorticoid receptor antagonists, such as spironolactone, support their inclusion in novel immunosuppressive strategies to inhibit new onset type II diabetic symptoms in post-transplantation patient populations. An appropriate level of suspicion and selective immunohistochemistry in these cases, particularly where no prior history of a known primary neuroendocrine neoplasm occurs, may help to diagnose a previously undetected neuroendocrine tumor elsewhere in the body and provide guidance for the appropriate treatment selection.
- |||||||||| Afinitor (everolimus) / Novartis, Sutent (sunitinib) / Pfizer
Journal: Anti-tumour activity of everolimus and sunitinib in neuroendocrine neoplasms. (Pubmed Central) - Apr 27, 2019
No additive toxicity of second-line MTT was confirmed. Based on these findings, and until reliable predictors of response become available, everolimus may be preferable to sunitinib when initiating molecular targeted therapies in progressive NENs.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: Retinal astrocytoma regression in tuberous sclerosis patients treated with everolimus. (Pubmed Central) - Apr 26, 2019
Retinal hamartomas, which are one of the major diagnostic features of TSC, tend to remain stable or gradually progress in the natural history of the disease. We report 2 patients with TSC treated with everolimus for SEGA in whom fundus photographs and spectral domain optical coherence tomography demonstrated regression of previously documented multiple retinal hamartomas in all 4 eyes.
- |||||||||| metformin / Generic mfg., everolimus / Generic mfg., exemestane / Generic mfg.
Trial completion date, Trial termination, Trial primary completion date, Metastases: Exemestane-RAD001-Metformin (clinicaltrials.gov) - Apr 24, 2019
P2, N=40, Terminated,
We report 2 patients with TSC treated with everolimus for SEGA in whom fundus photographs and spectral domain optical coherence tomography demonstrated regression of previously documented multiple retinal hamartomas in all 4 eyes. Trial completion date: Sep 2019 --> Feb 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2019 --> Feb 2019; Komen Foundation Funding Terminated
- |||||||||| carboplatin / Generic mfg., everolimus / Generic mfg., paclitaxel / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date, Metastases: Gastric Cancer RAD001 Study (clinicaltrials.gov) - Apr 20, 2019
P1/2, N=35, Completed,
Active, not recruiting --> Completed | N=42 --> 22 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2019 | Trial primary completion date: Dec 2019 --> Mar 2019
- |||||||||| Signifor LAR (pasireotide long acting release) / Recordati
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (clinicaltrials.gov) - Apr 20, 2019
P1, N=18, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: May 2020 --> Sep 2018 | Trial primary completion date: May 2020 --> Sep 2018
- |||||||||| veliparib (ABT-888) / AbbVie, Mekinist (trametinib) / Novartis, BeiGene, adavosertib (AZD1775) / AstraZeneca
Enrollment open, Phase classification, Metastases: MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations (clinicaltrials.gov) - Apr 20, 2019
P2, N=700, Recruiting,
Active, not recruiting --> Completed | Trial completion date: May 2020 --> Sep 2018 | Trial primary completion date: May 2020 --> Sep 2018 Suspended --> Recruiting | Phase classification: PN/A --> P2
- |||||||||| cisplatin / Generic mfg., everolimus / Generic mfg.
Trial completion, Trial completion date: NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer (clinicaltrials.gov) - Apr 20, 2019
P2, N=23, Completed,
Suspended --> Recruiting | Phase classification: PN/A --> P2 Active, not recruiting --> Completed | Trial completion date: Aug 2019 --> Jan 2019
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Trial completion date, Trial primary completion date, Metastases: Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Apr 19, 2019
P1, N=38, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Aug 2019 --> Jan 2019 Trial completion date: Jan 2019 --> Jan 2020 | Trial primary completion date: Jan 2019 --> Jan 2020
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Tropomyosin receptor kinase: a novel target in screened neuroendocrine tumors. (Pubmed Central) - Apr 19, 2019
...The human neuroendocrine pancreatic BON1, bronchopulmonary NCI-H727 and ileal GOT1 cell lines were treated with GNF-5837 alone and in combination with everolimus...We demonstrated that the pan-Trk inhibitor GNF-5837 has promising anti-tumoral properties in human NET cell lines expressing the TrkA receptor. Immunohistochemical or molecular screening for Trk expression particularly in pancreatic NETs might serve as predictive marker for molecular targeted therapy with Trk inhibitors.
- |||||||||| everolimus / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients (clinicaltrials.gov) - Apr 18, 2019
P=N/A, N=11, Completed,
Immunohistochemical or molecular screening for Trk expression particularly in pancreatic NETs might serve as predictive marker for molecular targeted therapy with Trk inhibitors. Enrolling by invitation --> Completed | N=300 --> 11 | Trial completion date: Nov 2018 --> Apr 2019 | Trial primary completion date: Oct 2018 --> Apr 2019
- |||||||||| Afinitor (everolimus) / Novartis
Review, Journal: Treatment options for PNET liver metastases: a systematic review. (Pubmed Central) - Apr 17, 2019
This beneficial treatment option for patients can minimize the drug dosage and the occurrence of adverse events. Treatment of patients with PNET metastases should be multidisciplinary and must be personalized according to the features of individual patients and tumors.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Impact of Immunosuppressive Drugs on the Metabolism of TÂ Cells. (Pubmed Central) - Apr 17, 2019
These examples raise the issue of how the modulation of these metabolic checkpoints can regulate T-cell activation, differentiation, and function. In this review we highlight emerging concepts about the modulation of metabolic reprogramming in T-cell responses by immunosuppressive drugs and how potential therapeutic interventions influence T-cell fate and effector function.
- |||||||||| everolimus / Generic mfg.
Biomarker, Trial completion date, Trial primary completion date, Monotherapy: Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation (clinicaltrials.gov) - Apr 16, 2019
P=N/A, N=40, Recruiting,
In this review we highlight emerging concepts about the modulation of metabolic reprogramming in T-cell responses by immunosuppressive drugs and how potential therapeutic interventions influence T-cell fate and effector function. Trial completion date: Mar 2019 --> Mar 2021 | Trial primary completion date: Mar 2018 --> Mar 2020
|
