- |||||||||| tacrolimus / Generic Mfg., Avastin (bevacizumab) / Roche, Afinitor (everolimus) / Novartis
Malignant Hepatic Epitheliod Hemangioendothelioma in a Patient With a Prior Liver Transplant (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1201;
Immunosuppression was also adjusted from tacrolimus to everolimus given anti-neoplastic properties of mTOR inhibitors over calcineurin inhibitors...Course is variable however prognosis is poor and there is no standardized management plan. VEGF inhibitors including Bevacizumab and Pazopanib have been a target of therapy given histologic positivity for target receptors, however results have been mixed to date.
- |||||||||| Journal: Immunotherapy for renal cell carcinoma - current status (Pubmed Central) - Aug 8, 2019
Nivolumab in combination with Ipilimumab will become a standard 1st line option for patients with intermediate and high risk profile according to IMDC. Further data are required regarding PD-1/PD-L1 inhibitors in combination with Bevacizumab and VEGFR-TKIs, respectively, including overall survival and side effect profile.
- |||||||||| Zybrestat (fosbretabulin) / Oncotelic
Enrollment change, Trial completion date, Trial termination, Combination therapy, Metastases: Fosbretabulin With Everolimus in Neuroendocrine Tumors With Progression (clinicaltrials.gov) - Aug 8, 2019
P1, N=17, Terminated,
N=30 --> 17 | Trial completion date: Jun 2019 --> Nov 2018 | Active, not recruiting --> Terminated; Part I completed. Part 2 will not be done due to sponsor decision.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Review, Journal: Neuroendocrine Tumors in Pediatrics. (Pubmed Central) - Aug 7, 2019
Awareness of these rare tumors and its management is crucial for optimal management. This article will focus on pediatric NETs and current advances in its management.
- |||||||||| Afinitor (everolimus) / Novartis
EXPERIENCE OF PEDIATRIC TUBEROUS SCLEROSIS COMPLEX (Poster Area) - Aug 7, 2019 - Abstract #SIOP2019SIOP_1060;
Everolimus treatment was recommended to our patient who had progressive growing bilateral renal angiomyolipoma and underwent partial nephrectomy, but treatment was refused by the family. It should be kept in mind that multidisciplinary approach is necessary in the follow-up and treatment of patients with TSC and physicians should be sensitive in determining the patients who need treatment in terms of current targeted treatments.
- |||||||||| Afinitor (everolimus) / Novartis
A PHASE 0 PHARMACODYNAMIC AND PHARMACOKINETIC STUDY OF EVEROLIMUS IN VESTIBULAR SCHWANNOMA (VS) AND MENINGIOMA PATIENTS (Poster Area) - Aug 7, 2019 - Abstract #SIOP2019SIOP_789;
In patients with meningioma or VS, treatment with everolimus leads to incomplete inhibition of mTORC1 signaling and upregulation phospho-ERK. These data may explain the limited anti-tumor effect of everolimus observed in clinical studies for pediatric and adult NF2 patients and identify upregulation of phospho-ERK as a likely resistance mechanism that could be addressed with combination therapies.
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date, Metastases: Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - Aug 7, 2019
P2, N=55, Active, not recruiting,
Trial completion date: Jul 2019 --> Jul 2020 | Trial primary completion date: Jul 2019 --> Jul 2020 Trial completion date: Jul 2019 --> Jul 2020 | Trial primary completion date: Jul 2019 --> Jul 2020
- |||||||||| Afinitor (everolimus) / Novartis, Sutent (sunitinib) / Pfizer, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Biomarker, Clinical, Clinical data, PD(L)-1 Biomarker, IO Biomarker: Very happy to see this important piece of translational science published in @CCR_AACR https://t.co/ilsnsTR8qz Evaluating the role of PD-L1 expression as a biomarker for clinical outcomes on Cabozantinib, Sunitinib, and Everolimus based on an analysis of #CABOSUN & #METEOR RCTs (Twitter) - Aug 4, 2019
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, PK/PD data, Journal: Pharmacokinetic Optimization of Everolimus Dosing in Oncology: A Randomized Crossover Trial. (Pubmed Central) - Aug 3, 2019
We demonstrated that switching from a once-daily to a twice-daily everolimus dose schedule reduces C max without negatively impacting C min or AUC24. These results merit further investigation of the twice-daily schedule in an effort to reduce everolimus toxicity while maintaining treatment efficacy.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Chronotherapy with defective circadian clock? (Pubmed Central) - Aug 3, 2019
These results merit further investigation of the twice-daily schedule in an effort to reduce everolimus toxicity while maintaining treatment efficacy. No abstract available
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Co-Delivery of Paclitaxel and Everolimus at the Optimal Synergistic Ratio: a Promising Solution for the Treatment of Breast Cancer. (Pubmed Central) - Aug 3, 2019
Cytotoxicity data demonstrated that PTX+EVER-loaded NPs were significantly less cytotoxic than the free drug combination in MCF-7 and SKBR3 BC cell lines following 72 h, suggesting that PTX+EVER-loaded NPs remain stable and retain the drug combination loaded within the core after 72 h. The uptake of FITC-labelled NPs in SKBR3 cells was evaluated by flow cytometry, with approximately 41 % of cells demonstrating detectable fluorescence after 24 h exposure. The thorough and systematic approach used in this study to determine and evaluate a synergistic PTX:EVER ratio in conjunction with a potentially promising delivery vector for the drug combination could offer a future clinical benefit for patients with BC.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Novel treatment and new drugs in epilepsy treatment. (Pubmed Central) - Aug 1, 2019
We finally describe the promising AEDs that are currently under development or testing. This article is a special issue concerning antiepileptic drugs in neurosurgical practice.
- |||||||||| Afinitor (everolimus) / Novartis
Biomarker, Journal: An update on the management of pancreatic neuroendocrine tumors. (Pubmed Central) - Aug 1, 2019
Presently, a number of clinical studies are ongoing to assess the efficacy of newer targeted agents alone and in combination with previous agents for the treatment of advanced PNETs. The authors reviewed the current treatment and also discussed the emerging agents and emphasized the need to identify biomarkers.
- |||||||||| Inlyta (axitinib) / Pfizer, Afinitor (everolimus) / Novartis, Sutent (sunitinib) / Pfizer
Journal: The outcome to axitinib or everolimus after sunitinib in metastatic renal cell carcinoma. (Pubmed Central) - Aug 1, 2019
This study reports no significantly differences between everolimus and axitinib in terms of both PFS and OS. Furthermore, the length of first-line treatment cannot be used as such a predictive factor and cannot suggest the use of a molecule compared with another.
- |||||||||| Votrient (pazopanib) / Novartis, sunitinib / Generic mfg., Zelboraf (vemurafenib) / Roche
Trial primary completion date, Metastases: ICK: Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. (clinicaltrials.gov) - Aug 1, 2019
P=N/A, N=43, Active, not recruiting,
Interestingly, effective inhibition of these pathways can be achieved by danusertib, or a combination of everolimus and arsenic trioxide, which provide possibilities of eliminating bone micrometastases using clinically established drugs. Trial primary completion date: Dec 2017 --> Dec 2019
- |||||||||| Journal: Interdisciplinary Recommendations for the Treatment of Metastatic Renal Cell Carcinoma (Pubmed Central) - Jul 28, 2019
...These improvements are also reflected in recent discussions about 3 and more lines of therapy.Sunitinib, pazopanib, the combination of bevacizumab and interferon alpha, and temsirolimus are approved for first-line therapy of mRCC...Everolimus (after tyrosine kinase inhibitor (TKI) treatment), sorafenib (after cytokines) and axitinib (after treatment with sunitinib or cytokines) are other compounds available for second-line therapy.3 new substances have recently been approved for second-line therapy: Nivolumab, cabozantinib, and lenvatinib combined with everolimus can be used after VEGF-targeted treatment has failed...Study results from a phase III trial suggest that the sequences sorafenib-sunitinib and sunitinib-sorafenib are equally effective.The purpose of an interdisciplinary expert meeting on RCC was to work out joint treatment recommendations based on current data and clinical experience and to integrate them into clinical routine practice. The results are presented in this publication.
- |||||||||| everolimus / Generic mfg., fulvestrant / Generic mfg.
Clinical, P2 data, Journal: Randomized Phase II Trial of Fulvestrant Plus Everolimus or Placebo in Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy: Results of PrE0102. (Pubmed Central) - Jul 28, 2019
Adverse events of all grades occurred more often in the everolimus arm, including oral mucositis (53% v 12%), fatigue (42% v 22%), rash (38% v 5%), anemia (31% v. 6%), diarrhea (23% v 8%), hyperglycemia (19% v 5%), hypertriglyceridemia (17% v 3%), and pneumonitis (17% v 0%), although grade 3 to 4 events were uncommon. Conclusion Everolimus enhances the efficacy of fulvestrant in AI-resistant, ER-positive metastatic breast cancer.
- |||||||||| Avastin (bevacizumab) / Roche, Afinitor (everolimus) / Novartis
Review, Journal: Emerging and Novel Treatments for Pituitary Tumors. (Pubmed Central) - Jul 28, 2019
...To date, for aggressive PitNETs, temozolomide (TMZ) has been the most used therapeutic option, and has resulted in an improvement in the five-year survival rate in responders...The therapies that currently show the most promise (based on the achievement of partial radiological response in a certain number of cases) are immune checkpoint inhibitors, peptide receptor radionuclide therapy, and vascular endothelial growth factor receptor-targeted therapy. In the future, further improvement of these therapies and the development of other novel therapies, their use in personalized medicine, and a better understanding of combination therapies, will hopefully result in better outcomes for patients bearing aggressive PitNETs.
- |||||||||| darTregs / National Institute of Allergy and Infectious Diseases
Trial termination: deLTa: Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (clinicaltrials.gov) - Jul 26, 2019
P1, N=15, Terminated,
mTOR inhibitors and checkpoint inhibitors might be useful for the treatment of a subset of diffuse-type GCs which may develop from intestinal-type GCs. Active, not recruiting --> Terminated; The trial could not be completed within the grant timeline.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: An Atypical Presentation of Thrombotic Microangiopathy After Lung Transplant: A Case Report. (Pubmed Central) - Jul 23, 2019
TMA may be a serious complication after lung transplantation and the risk is higher when a combination of tacrolimus and everolimus is used. Renal biopsy findings are essential to confirm the final diagnosis of TMA, allowing for a change in immunosuppression to prevent permanent and severe renal damage.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal, Combination therapy: Dual Imaging With 68Ga-DOTATOC and 18F-FDG PET for Planning and Follow-up of PRRT in Combination With Temozolomide Treatment in a Patient With a Metastatic Neuroendocrine Tumor. (Pubmed Central) - Jul 19, 2019
Before this treatment, the patient had already undergone a series of therapies, including biotherapy, everolimus, 5 cycles of radiopeptide therapies, radiotherapy, and bone-protecting therapy with bisphosphonate and receptor activator of NF-κB ligand, each of which temporarily stalled the progress of the disease. After combined treatment with radiopeptide therapy and temozolomide, the patient showed a very good response in all tumor lesions, including the FDG-positive ones.
- |||||||||| everolimus / Generic mfg., Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Clinical, P3 data, Journal, HEOR: Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. (Pubmed Central) - Jul 19, 2019
P3
Conclusion In patients with advanced renal cell carcinoma, relative to everolimus, cabozantinib generally maintained QoL to a similar extent. Compared with everolimus, cabozantinib extended TTD overall and markedly improved TTD in patients with bone metastases.
- |||||||||| Afinitor (everolimus) / Novartis
Preclinical, Journal, IO Biomarker: RhoA G17V is sufficient to induce autoimmunity and promotes T cell lymphomagenesis in mice. (Pubmed Central) - Jul 17, 2019
Transplanted tumors were responsive to the mTOR inhibitor everolimus, providing a possible strategy for targeting RhoA G17V. Taken together, these data indicate that RhoA G17V contributes to both neoplastic and paraneoplastic phenotypes like those observed in patients with TFH lymphomas.
- |||||||||| Trial completion date, Trial primary completion date: Efficacy and Safety of Precision Therapy in Refractory Tumor (clinicaltrials.gov) - Jul 16, 2019
P2, N=300, Recruiting,
Taken together, these data indicate that RhoA G17V contributes to both neoplastic and paraneoplastic phenotypes like those observed in patients with TFH lymphomas. Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
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