- |||||||||| everolimus / Generic mfg., mycophenolate sodium / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date, Post-transplantation: Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function (clinicaltrials.gov) - Oct 15, 2019 P3, N=329, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2019
- |||||||||| everolimus / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date, Surgery: Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex. (clinicaltrials.gov) - Oct 15, 2019 P4, N=40, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2020 | Trial primary completion date: Dec 2019 --> May 2019 Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> Oct 2020 | Trial primary completion date: Jan 2022 --> Oct 2020
- |||||||||| Inlyta (axitinib) / Pfizer, Sutent (sunitinib) / Pfizer
Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world, Metastases: ADONIS: Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting (clinicaltrials.gov) - Oct 15, 2019 P=N/A, N=750, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> Oct 2020 | Trial primary completion date: Jan 2022 --> Oct 2020 Trial completion date: Jul 2019 --> May 2021 | Trial primary completion date: Jul 2019 --> May 2021
- |||||||||| tacrolimus / Generic Mfg., Afinitor (everolimus) / Novartis
A Rare Case of Monoclonal Immunoglobulin Deposition Disease (MIDD) in a Transplant Recipient (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_4698; The etiology for graft-failure remains elusive, though MIDD as a contributor is a theoretical possibility. Our case shows the importance of early transplant biopsy with the performance of IF and EM for all patients with suspected glomerular pathology.
- |||||||||| Afinitor (everolimus) / Novartis
Application of the IBox Clinical Trial Simulation Tool to Project Long-Term Kidney Allograft Outcome in the TRANSFORM Study (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_3464; P=N/A, P4 Conclusion The iBox system confirms the non-inferiority of everolimus vs MPA 10 years after patient's randomization in the RCT. Given the unmet need for surrogate endpoint for clinical trials, this study shows the potential of a clinical trial simulation tool to fast track the development and approval of pharmaceutical agents.
- |||||||||| MK-2206 / Merck (MSD)
Trial termination: Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer (clinicaltrials.gov) - Oct 10, 2019 P2, N=43, Terminated, However, concentration bias of the QMS assay significantly changed within 6 years, emphasizing the need for long-term, independent performance tracking of TDM assays, including FDA-approved assays. Active, not recruiting --> Terminated
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: Chemoprevention in Patients with Peutz-Jeghers Syndrome: Lessons Learned. (Pubmed Central) - Oct 10, 2019 Active, not recruiting --> Terminated Due to accrual problems, no conclusions can be drawn about the value of everolimus in PJS treatment, questioning the feasibility of this agent for chemoprevention.
- |||||||||| Afinitor (everolimus) / Novartis
Journal, IO Biomarker: Therapeutic inhibition of Mcl-1 blocks cell survival in estrogen receptor-positive breast cancers. (Pubmed Central) - Oct 9, 2019 Similarly, combined use of the selective Mcl-1 inhibitor VU661013 with ABT-263 resulted in tumor cell apoptosis and diminished tumor growth in vivo. These findings suggest that rapid Mcl-1 translation drives ABT-263 resistance, but can be combated directly using emerging Mcl-1 inhibitors, or indirectly through existing and approved mTOR inhibitors.
- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial suspension, Trial primary completion date, Combination therapy: Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score (clinicaltrials.gov) - Oct 9, 2019 P2, N=17, Suspended, These findings suggest that rapid Mcl-1 translation drives ABT-263 resistance, but can be combated directly using emerging Mcl-1 inhibitors, or indirectly through existing and approved mTOR inhibitors. Trial completion date: Dec 2018 --> Dec 2020 | Completed --> Suspended | Trial primary completion date: Jul 2017 --> Jul 2020
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Journal: TORC1 inhibition enhances immune function and reduces infections in the elderly. (Pubmed Central) - Oct 9, 2019 In addition, we observed an up-regulation of antiviral gene expression and an improvement in the response to influenza vaccination in this treatment group. Thus, selective TORC1 inhibition has the potential to improve immune function and reduce infections in the elderly.
- |||||||||| Afinitor (everolimus) / Novartis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Review, Journal: Lenvatinib Long-Term Responses in Refractory Thyroid Cancer: Our Mono-Institutional Real-Life Experience with the Multidisciplinary Approach and Review of Literature. (Pubmed Central) - Oct 8, 2019 Hypertension, diarrhea, weight loss, proteinuria, fatigue, and palmar-plantar erythrodysesthesia are reported among the most frequent AEs, often leading to discontinuations or dose modifications. This paper reports a case series focusing on the role of the immediate multidisciplinary approach to manage AEs.
- |||||||||| Afinitor (everolimus) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Interventional pharmacoeconomics: A new discipline for a cost-constrained environment (Lomond Auditorium) - Oct 7, 2019 - Abstract #NCRI2019NCRI_5; There are four basic strategies to reduce costs and potentially toxicity, without negatively impacting efficacy: 1) substitution of a therapeutic alternative (e.g., sirolimus for everolimus); 2) lower dosages (e.g., abiraterone 250 mg with food); 3) less frequent dosing (e.g., nivolumab 480 mg every 8 weeks); 4) shorter duration of dosing (e.g., PERSEPHONE study). Notably, in a single payer system such as the NHS, these studies are self-funding, if the drug savings accrued during the study (in the experimental arm) can be repurposed to fund the research costs.
- |||||||||| polyTregs / National Institute of Allergy and Infectious Diseases
Enrollment change: TASK: Treg Therapy in Subclinical Inflammation in Kidney Transplantation (clinicaltrials.gov) - Oct 4, 2019 P1/2, N=30, Recruiting, This case constitutes one of the few reports of the treatment of primary thymic carcinoid with everolimus and octreotide. N=45 --> 30
- |||||||||| cyclophosphamide / Generic mfg., everolimus / Generic mfg., mesna / Generic mfg.
Trial completion date, Trial primary completion date: LITMMUS-MGH: Liver Transplantation With Tregs at MGH (clinicaltrials.gov) - Oct 3, 2019 P1/2, N=9, Recruiting, N=45 --> 30 Trial completion date: Feb 2025 --> Mar 2023 | Trial primary completion date: Feb 2025 --> Mar 2023
- |||||||||| everolimus / Generic mfg.
Enrollment change: SCHEDULE Follow Up Visit 5-7 yr (clinicaltrials.gov) - Oct 3, 2019 P4, N=95, Completed, Trial completion date: Feb 2025 --> Mar 2023 | Trial primary completion date: Feb 2025 --> Mar 2023 N=50 --> 95
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Multi-disciplinary management of refractory insulinomas. (Pubmed Central) - Oct 2, 2019 Early referral to a dedicated neuroendocrine multidisciplinary team is critical considering the array of medical, oncological, interventional radiological and nuclear medical options. We discuss the evolving armamentarium for insulinomas when standard medical therapy fails.
- |||||||||| Afinitor (everolimus) / Novartis
The Use of New Bionanopolymer Stent Coatings for Coronary Stenting () - Oct 1, 2019 - Abstract #TCT2019TCT_586; Patients underwent stenting with stent not less than generation II with everolimus drug elution...Conclusion The results obtained allow the authors to consider the P4 biopolymer substrate as the most promising material for vascular stents. Work with monocytes is currently ongoing.
- |||||||||| cyclophosphamide / Generic mfg., everolimus / Generic mfg., mesna / Generic mfg.
Trial withdrawal: LITMMUS-UCSF: Liver Transplantation With Tregs at UCSF (clinicaltrials.gov) - Oct 1, 2019 P1/2, N=0, Withdrawn, With new designs and materials, the length of the stent may not be as important a predictor of events as it was in the past. Not yet recruiting --> Withdrawn
- |||||||||| sirolimus / Generic mfg.
Enrollment closed, Enrollment change, Trial primary completion date: MIDAS: Safety and Durability of Sirolimus for Treatment of LAM (clinicaltrials.gov) - Sep 30, 2019 P=N/A, N=600, Active, not recruiting, Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020 Recruiting --> Active, not recruiting | N=300 --> 600 | Trial primary completion date: Apr 2019 --> Apr 2020
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Multiscale systems pharmacological analysis of everolimus action in hepatocellular carcinoma. (Pubmed Central) - Sep 28, 2019 In conclusion, a multiscale QSP/PK/PD model elucidating everolimus lack of efficacy in HCC patients was successfully developed and predicted PFS reasonably well compared to observed clinical findings. This model may provide insights into clinical response to everolimus-based therapy and serve as a valuable tool for the clinical translation of efficacy for novel mTOR inhibitors.
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