- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Evaluation of neratinib (N), pembrolizumab (P), everolimus (E), and nivolumab (V) in patients (pts) with fibrolamellar carcinoma (FLC). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_247; P2 Several case studies evaluating N-based combo with checkpoint inhibitors administered under compassionate use demonstrated that NP led to 1 PR, and the triplet of NPE to prolonged SD. These are case-limited observations but are critical and worth evaluating further in upcoming clinical trials given the continued lack of a standard of care therapy for pts with FLC.
- |||||||||| 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) - Dec 8, 2020 P1, N=38, Active, not recruiting, These are case-limited observations but are critical and worth evaluating further in upcoming clinical trials given the continued lack of a standard of care therapy for pts with FLC. Trial completion date: Jan 2021 --> Apr 2021 | Trial primary completion date: Jan 2021 --> Apr 2021
- |||||||||| everolimus / Generic mfg.
Clinical, Journal: Fetal cardiac tumors: prenatal diagnosis, management and prognosis in 18 cases (Pubmed Central) - Dec 5, 2020 Everolimus therapy at a dose of 2x0.25 mg twice a week for three months was started in the postnatal period...Rhabdomyoma are usually multiple and associated with TSC. Rhabdomyomas with TSC are larger, but most regress spontaneously or respond well to medical treatment after birth, and have an excellent long-term prognosis.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Elderly patients (pts) with advanced Renal Cell Carcinoma (aRCC) treated with Nivolumab (N): A subgroup analysis from the WITNESS real-world study in France () - Dec 3, 2020 - Abstract #EMUC2020EMUC_144; P=N/A Pts were mainly treated in first-line with sunitinib (44% vs 61%) or pazopanib (41% vs 31%)...Among pts who discontinued N (n=162), 49% of elderly pts received subsequent therapy compared to 69% in <75 y.o. population: cabozantinib (67% in elderly vs 83%), axitinib (15% vs 10%) and everolimus (11% vs 5%)...Conclusions In this subpopulation of elderly pts of the WITNESS study, effectiveness results were comparable with those observed in both the overall population in WITNESS and in CM 025. Safety results were consistent with the known safety profile of N.
- |||||||||| everolimus / Generic mfg.
Trial completion, Metastases: MAIN-A: Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients (clinicaltrials.gov) - Dec 3, 2020 P3, N=110, Completed, Conclusions In the group of patients with disseminated renal cell clear cell carcinoma treated with molecular targeted therapy in first and second line total tumour burden was associated with a decrease in overall survival and response to treatment. Total tumour burden within the lungs was associated with a decrease in overall survival and response to treatment in patients treated in the first line. Active, not recruiting --> Completed
- |||||||||| everolimus / Generic mfg.
[VIRTUAL] 117LU-DOTA-TATE AS A THERAPEUTIC WEAPON IN NEUROENDOCRINE TUMORS (NETS): A CASE REPORT () - Dec 2, 2020 - Abstract #ENEA2020ENEA_33; The patient remained asymptomatic and without signs of disease progression for 4 years, after PRRT, showing how effective this treatment can be, with a very good safety profile and no significant side effects. Thus, PRRnT appears to be the best therapeutic option for progressive GET-nETs under SSA treatment, given the excellent relationship between effectiveness and tolerability.
- |||||||||| everolimus / Generic mfg.
[VIRTUAL] SPLICING DYSREGULATION IN PANCREATIC NEUROENDOCRINE TUMORS: CONTRIBUTION OF CELF4 SPLICING FACTOR TO PANNET AGGRESSIVENESS () - Dec 2, 2020 - Abstract #ENEA2020ENEA_7; Moreover, CELF4 silencing altered key signaling pathways and hampered the response of both cell lines to everolimus treatment, thus that CELF4 may play a role in tumor cell aggressiveness and that it could be a suitable actionable tool in PannETs...Our results demonstrate that the splicing factor CELF4 is severely dysregulated in PannETs, where it could influence tumor development and aggressiveness. These findings provide original evidence inviting to further explore this splicing factor as novel a potential diagnostic marker and treatment target in PannETs.
- |||||||||| everolimus / Generic mfg.
[VIRTUAL] Multifocal Hemorrhagic Tumors in a Young Adult () - Dec 2, 2020 - Abstract #ASDP2020ASDP_422; The patient underwent amputation of the left fifth toe, wide local excision of the heel lesion, and was started on systemic everolimus...PMH is a rare vascular tumor that can mimic other spindled and epithelioid entities. This case demonstrates a dramatic clinical presentation of PMH with metastases and highlights PMH as a cause of multifocal hemorrhagic tumors in young adults.
- |||||||||| metformin / Generic mfg., letrozole / Generic mfg., everolimus / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma (clinicaltrials.gov) - Dec 2, 2020 P2, N=62, Active, not recruiting, Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Dec 2020 --> Mar 2021 Trial completion date: Oct 2020 --> Oct 2023 | Trial primary completion date: Oct 2020 --> Oct 2022
- |||||||||| everolimus / Generic mfg.
Journal: Predicting Radiation Resistance in Breast Cancer with Expression Status of Phosphorylated S6K1. (Pubmed Central) - Dec 1, 2020 Furthermore, the combination of radiation with treatment of everolimus, an mTOR-S6K1 pathway inhibitor, sensitised CD44/CD24 MCF7 cells to a greater extent than MCF7 cells. This study provides in vivo and in vitro evidence for p-S6K1 expression status as an important marker for predicting the resistance to radiotherapy and as a possible target for radio-sensitization in breast cancer patients.
- |||||||||| everolimus / Generic mfg., gefitinib / Generic mfg.
Journal: Co-targeting EGFR and mTOR with gefitinib and everolimus in triple-negative breast cancer cells. (Pubmed Central) - Dec 1, 2020 Gene and protein expression analysis revealed significant downregulation of cell cycle regulators after exposure to combined treatment. Collectively, these results suggested that dual inhibition of mTOR and EGFR may be an effective treatment for TNBC with activating mutations of PI3K.
- |||||||||| cyclophosphamide / Generic mfg., everolimus / Generic mfg.
Enrollment closed, Trial completion date, Post-transplantation: OCTET-Ever: Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT (clinicaltrials.gov) - Dec 1, 2020 P2, N=19, Active, not recruiting, Collectively, these results suggested that dual inhibition of mTOR and EGFR may be an effective treatment for TNBC with activating mutations of PI3K. Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Dec 2020
- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial primary completion date: CLEVER-ACS: Controlled Level EVERolimus in Acute Coronary Syndromes (clinicaltrials.gov) - Nov 30, 2020 P1/2, N=150, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Dec 2020 Trial completion date: Dec 2020 --> Sep 2021 | Trial primary completion date: Dec 2020 --> Sep 2021
- |||||||||| everolimus / Generic mfg.
[VIRTUAL] Everolimus as a precision medicine for epilepsy due to pathogenic variants in DEPDC5 () - Nov 28, 2020 - Abstract #AES2020AES_298; Both cases had previously failed more than six anti-seizure medicines and following initiation of everolimus experienced a significant improvement in seizure control due to an adoption of a precision medicine approach. Funding: This work was supported by research grants from Epilepsy Ireland, the Health Research Board (MRCG-HRB-2018-05) and Science Foundation Ireland (SFI) (16/RC/3948 and 13/CDA/2223) and co-funded under the European Regional Development Fund and by FutureNeuro industry partners
- |||||||||| imlunestrant (LY3484356) / Eli Lilly
Trial primary completion date, Combination therapy, Monotherapy, Metastases: EMBER: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (clinicaltrials.gov) - Nov 25, 2020 P1a/1b, N=460, Recruiting, Funding: This work was supported by research grants from Epilepsy Ireland, the Health Research Board (MRCG-HRB-2018-05) and Science Foundation Ireland (SFI) (16/RC/3948 and 13/CDA/2223) and co-funded under the European Regional Development Fund and by FutureNeuro industry partners Trial primary completion date: Oct 2020 --> Feb 2021
- |||||||||| xentuzumab (BI-836845) / Boehringer Ingelheim
Trial completion date, Combination therapy, Metastases: BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer (clinicaltrials.gov) - Nov 24, 2020 P1, N=164, Active, not recruiting, Trial primary completion date: Oct 2020 --> Feb 2021 Trial completion date: Nov 2020 --> Jul 2021
- |||||||||| doxycycline / Generic mfg., Pierre Fabre, everolimus / Generic mfg., sirolimus / Generic mfg.
Clinical, Journal: The efficacy and safety of pharmacological treatments for lymphangioleiomyomatosis. (Pubmed Central) - Nov 22, 2020 Doxycycline and triptorelin were not recommended for the treatment of LAM because no beneficial outcomes were consistently observed. The efficacy and safety of combination therapy remain to be further explored.
- |||||||||| rapamycin topical (PTX-022) / Palvella Therapeutics, Ligand
Journal: Structural insights into CYP107G1 from rapamycin-producing Streptomyces rapamycinicus. (Pubmed Central) - Nov 21, 2020 Hence, CYP107G1 has a relatively rigid structure with versatile loops to accommodate a bulky substrate. The everolimus molecule is bound to the substrate-binding pocket in the shape of a squeezed donut, and its elongated structure is bound perpendicular to a planar heme plane and I-helix.
- |||||||||| Votrient (pazopanib) / Novartis, sunitinib / Generic mfg., Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date, Metastases: ICK: Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. (clinicaltrials.gov) - Nov 20, 2020 P=N/A, N=43, Active, not recruiting, Active, not recruiting --> Terminated Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| everolimus / Generic mfg., sirolimus / Generic mfg.
Journal: Direct regulation of fibroblast growth factor 23 by energy intake through mTOR. (Pubmed Central) - Nov 19, 2020 Cells incubated with HG and mechanistic target of rapamycin (mTOR) inhibitors expressed low mRNA FGF23, similar to the values obtained in LG. In conclusion, this study shows a direct regulation of FGF23 production by energy availability and demonstrates that the mTOR signaling pathway plays a central role in this regulatory system.
- |||||||||| Trial completion date, Trial primary completion date: Efficacy and Safety of Precision Therapy in Refractory Tumor (clinicaltrials.gov) - Nov 18, 2020
P2, N=300, Recruiting, In conclusion, this study shows a direct regulation of FGF23 production by energy availability and demonstrates that the mTOR signaling pathway plays a central role in this regulatory system. Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Jun 2020 --> Jun 2023
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