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Dose escalation

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https://www.readbyqxmd.com/read/27911276/the-mtor-inhibitor-everolimus-in-combination-with-azacitidine-in-patients-with-relapsed-refractory-acute-myeloid-leukemia-a-phase-ib-ii-study
#1
Peter Tan, Ing Soo Tiong, Shaun Fleming, Giovanna Pomilio, Nik Cummings, Mark Droogleever, Julie McManus, Anthony Schwarer, John Catalano, Sushrut Patil, Sharon Avery, Andrew Spencer, Andrew Wei
Therapeutic options are limited in relapsed/refractory acute myeloid leukemia (AML). We evaluated the maximum tolerated dose (MTD) and preliminary efficacy of mammalian target of rapamycin (mTOR) inhibitor, everolimus (days 5-21) in combination with azacitidine 75 mg/m2 subcutaneously (days 1-5 and 8-9 every 28 days) in 40 patients with relapsed (n = 27), primary refractory (n = 11) or elderly patients unfit for intensive chemotherapy (n = 2). MTD was not reached following everolimus dose escalation (2.5, 5 or 10 mg; n = 19) to the 10 mg dose level which was expanded (n = 21)...
November 29, 2016: Oncotarget
https://www.readbyqxmd.com/read/27911138/phase-1-dose-escalation-study-of-oral-abexinostat-for-the-treatment-of-patients-with-relapsed-refractory-higher-risk-myelodysplastic-syndromes-acute-myeloid-leukemia-or-acute-lymphoblastic-leukemia
#2
Norbert Vey, Thomas Prebet, Claire Thalamas, Aude Charbonnier, Jerome Rey, Ioana Kloos, Emily Liu, Ying Luan, Remus Vezan, Thorsten Graef, Christian Recher
Histone deacetylase (HDAC) inhibitor abexinostat is under investigation for the treatment of various cancers. Epigenetic changes including aberrant HDAC activity are associated with cancers, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL). In this phase 1 dose-escalation study, 17 patients with relapsed/refractory higher-risk MDS, AML, or ALL received oral abexinostat (60, 80 [starting dose], 100, or 120 mg) twice daily (bid) on Days 1-14 of 21-day cycles...
December 2, 2016: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27911128/s-1-in-combination-with-docetaxel-and-oxaliplatin-in-patients-with-advanced-gastro-esophageal-adenocarcinoma-two-parallel-phase-1-2a-studies
#3
Per Pfeiffer, Camilla Qvortrup, Merete Krogh, Katrine Schoennemann, Lene W Vestermark, Helle A Jensen, Jon K Bjerregaard
BACKGROUND: Docetaxel in combination with cisplatin and 5-fluorouracil (5-FU) is one of several standard chemotherapy regimens for patients with advanced gastro-esophageal adenocarcinoma (aGEA) in Europe. To enable outpatient treatment, we evaluated the maximum tolerated dose (MTD), recommended dose (RD), dose limiting toxicity (DLT) and safety of docetaxel in combination with oxaliplatin (O) and S-1 (DOS) in Caucasian patients with aGEA. METHODS: We present final results of two parallel phase 1/2a studies (3 + 3 design)...
December 2, 2016: Acta Oncologica
https://www.readbyqxmd.com/read/27910037/effect-of-activated-charcoal-on-rivaroxaban-complex-absorption
#4
Edouard Ollier, Sophie Hodin, Julien Lanoiselée, Jean Escal, Sandrine Accassat, Elodie De Magalhaes, Thierry Basset, Laurent Bertoletti, Patrick Mismetti, Xavier Delavenne
OBJECTIVE: To quantify the impact of activated charcoal (AC) on rivaroxaban exposure in healthy volunteers. METHODS: This was an open-label study with an incomplete cross-over design of single-dose rivaroxaban (40 mg) administered alone or with AC in 12 healthy volunteers. The study comprised three treatment periods in randomised sequence, one with rivaroxaban administered alone and two with AC given at 2, 5 or 8 h post-dose. Rivaroxaban plasma concentration was measured in blood samples drawn at 16 time points...
December 2, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27907978/comparison-of-the-single-dose-pharmacokinetics-pharmacodynamics-and-safety-of-two-novel-oral-formulations-of-dimethandrolone-undecanoate-dmau-a-potential-oral-male-contraceptive
#5
R Ayoub, S T Page, R S Swerdloff, P Y Liu, J K Amory, A Leung, L Hull, D Blithe, A Christy, J H Chao, W J Bremner, C Wang
Dimethandrolone (DMA, 7α,11β-dimethyl-19-nortestosterone) has both androgenic and progestational activities, ideal properties for a male hormonal contraceptive. In vivo, dimethandrolone undecanoate (DMAU) is hydrolyzed to DMA. We showed previously that single oral doses of DMAU powder in capsule taken with food are well tolerated and effective at suppressing both LH and testosterone (T), but absorption was low. We compared the pharmacokinetics and pharmacodynamics of two new formulations of DMAU, in castor oil and in self-emulsifying drug delivery systems (SEDDS), with the previously tested powder formulation...
December 1, 2016: Andrology
https://www.readbyqxmd.com/read/27905916/study-protocol-a-dose-escalating-phase-2-study-of-oral-lisdexamfetamine-in-adults-with-methamphetamine-dependence
#6
Nadine Ezard, Adrian Dunlop, Brendan Clifford, Raimondo Bruno, Andrew Carr, Alexandra Bissaker, Nicholas Lintzeris
BACKGROUND: The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder...
December 1, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27905362/-characteristics-of-parkinson-s-disease-course-in-the-heterozygous-carriage-of-mutations-in-the-glucocerebrosidase-a-gene
#7
O A Gan'kina, E E Vasenina, O S Levin, E Yu Fedotova, S N Illarioshkin
Parkinson's disease (PD) is a common neurodegenerative disease. Literature sources indicate the association of PD and mutations in the glucocerebrosidase A (GBA) gene. According to our study, the frequency of the two most common mutations in the GBA gene, N370S and L444P, is 1.85%. Mutation carriers have slower progression of motor symptoms, but are more likely to develop drug-induced motor fluctuations and dyskinesia. In carriers of GBA mutations, the severity of cognitive impairment corresponds to age-matched patients without mutations...
2016: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/27902470/phase-i-study-of-qlnc120-a-novel-egfr-and-her2-kinase-inhibitor-in-pre-treated-patients-with-her2-overexpressing-advanced-breast-cancer
#8
Tongtong Zhang, Qing Li, Shanshan Chen, Yang Luo, Ying Fan, Binghe Xu
This study evaluated the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), pharmacokinetic profile, and preliminary antitumor activity of QLNC120, an inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), in HER2 overexpressing advanced breast cancer patients. In addition, the prognostic biomarkers of QLNC120 were investigated. QLNC120 was administered as a single dose, followed by 7 days observation, and then once daily consecutively. Scheduled dose escalation was 450mg, 750mg, 1000mg and 1250mg...
November 25, 2016: Oncotarget
https://www.readbyqxmd.com/read/27899808/autoimmunity-to-hsp60-during-diet-induced-obesity-in-mice
#9
M E Şelli, G Wick, D C Wraith, A C Newby
Adaptive immunity has been implicated in adipose tissue inflammation, obesity and its adverse metabolic consequences. No obesity-related autoantigen has yet been identified, although heat shock protein 60 (HSP60) has been implicated in other autoimmune diseases. We investigated whether feeding a high fat diet to C57BL/6J mice would cause autoimmunity to HSP60 and whether immunomodulation with peptides from HSP60 would reverse the resulting obesity or metabolic dysfunction. Obese mice had higher circulating levels of HSP60 associated with increased T-lymphocyte proliferation responses and the emergence of circulating IgG1 and IgG2c antibody levels against HSP60...
November 30, 2016: International Journal of Obesity: Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/27899263/adalimumab-dose-escalation-is-effective-and-well-tolerated-in-crohn-s-disease-patients-with-secondary-loss-of-response-to-adalimumab
#10
Nicolas Duveau, Maria Nachury, Romain Gerard, Julien Branche, Vincent Maunoury, Medina Boualit, Pauline Wils, Pierre Desreumaux, Benjamin Pariente
BACKGROUND: Although adalimumab is effective in Crohn's disease, most patients experience a loss of response over time. The aim of the present study was to evaluate efficacy and safety of adalimumab dose escalation and identify predictors of a clinical response in Crohn's disease patients with a secondary loss of response. METHODS: We performed a retrospective and observational study including all Crohn's disease patients who underwent dose escalation of adalimumab after a secondary loss of response from 2007 to 2015...
November 14, 2016: Digestive and Liver Disease
https://www.readbyqxmd.com/read/27898257/assessment-of-nifedipine-therapy-in-hyperinsulinemic-hypoglycemia-due-to-mutations-in-the-abcc8-gene
#11
M Güemes, P Shah, S Silvera, K Morgan, C Gilbert, L Hinchey, K Hussain
CONTEXT: Previous case reports have documented the effectiveness of L-type calcium channel blockers (such as Nifedipine and Verapamil) for treating different forms of hyperinsulinemic hypoglycemia (HH). OBJECTIVE: To systematically assess the glycemic response to Nifedipine therapy in 11 patients with HH due to mutations in the ABCC8 gene. DESIGN: Dose escalation of Nifedipine therapy Setting: Inpatients at a tertiary hospital Patients or Other Participants: 11 children with diazoxide unresponsive HH due to mutations in the ABCC8 gene...
November 29, 2016: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/27897060/potential-for-adaptive-dose-escalation-in-radiotherapy-for-patients-with-locally-advanced-non-small-cell-lung-cancer-in-a-low-mid-income-setting
#12
Sushma Agrawal, Sunil Kumar, Anil Kumar Maurya
OBJECTIVE: To evaluate the effect of tumour volume regression on adaptive treatment planning, reduction in doses to organs at risk (OAR) and dose escalation. METHODS: 20 patients undergoing radical chemoradiotherapy were imaged in fifth week of radiotherapy (CT_45) to evaluate differences in tumour volume regression between concurrent (CONC) and sequential chemoradiotherapy (SEQ). Replanning was done on CT_45 in those with >20% regression (n=10) and evaluated for change in target coverage indices (coverage index [CI], external volume index [EI]) and doses to OAR [mean lung dose, V20 and V5 of whole and ipsilateral lung (MLDWL, V20WL, V5WL, MLDIL, V20IL, V5IL), mean esophagus dose, V50 esophagus and maximum spinal cord doses]...
November 29, 2016: British Journal of Radiology
https://www.readbyqxmd.com/read/27896689/pharmacokinetics-of-daratumumab-following-intravenous-infusion-in-relapsed-or-refractory-multiple-myeloma-after-prior-proteasome-inhibitor-and-immunomodulatory-drug-treatment
#13
Pamela L Clemens, Xiaoyu Yan, Henk M Lokhorst, Sagar Lonial, Nedjad Losic, Imran Khan, Richard Jansson, Tahamtan Ahmadi, Kristen Lantz, Honghui Zhou, Thomas Puchalski, Xu Steven Xu
Daratumumab is a CD38 monoclonal antibody recently approved for the treatment of multiple myeloma (MM). We report daratumumab pharmacokinetic data from GEN501, a phase I/II dose-escalation (0.005-24 mg/kg) and dose-expansion (8 or 16 mg/kg) study, and SIRIUS, a phase II study (8 or 16 mg/kg), in relapsed or refractory MM. Noncompartmental analysis was conducted to characterize daratumumab pharmacokinetics, and, in both studies, daratumumab exhibited nonlinear pharmacokinetic characteristics. Decreasing daratumumab clearance with increasing dose suggests saturation of target-mediated clearance at higher dose levels, whereas decreasing clearance over time with repeated dosing may be due to tumor burden reductions as CD38-positive cells are eliminated...
November 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27896522/tapering-biologics-in-rheumatoid-arthritis-a-pragmatic-approach-for-clinical-practice
#14
Aleksander Lenert, Petar Lenert
Optimal rheumatoid arthritis (RA) therapy in daily clinical practice is based on the treat-to-target strategy. Quicker escalation of therapy and earlier introduction of biological disease-modifying anti-rheumatic drugs have led to improved outcomes in RA. However, chronic immunosuppressive therapy is associated with adverse events and higher costs. In addition, our patients frequently express a desire for lower dosing and drug holidays. Current clinical practice guidelines from the American College of Rheumatology and European League Against Rheumatism suggest that rheumatologists consider tapering treatment after achieving remission...
November 28, 2016: Clinical Rheumatology
https://www.readbyqxmd.com/read/27895235/benzodiazepine-initiation-and-dose-escalation-a-risk-factor-for-inpatient-falls
#15
Brian W Skinner, Elizabeth V Johnston, Lindsay M Saum
BACKGROUND: Benzodiazepines (BZDs) place patients at a significant risk of falling. The current literature does not address if this risk is increased during initiation or dose escalations of BZDs. OBJECTIVE: To determine if initiation or dose escalations of BZD regimens are associated with an increased risk of falls in hospitalized patients compared with patients maintained on their home dose or who had their dose decreased from baseline. METHODS: This retrospective case-control study evaluated hospitalized patients aged 45 years or older who received a BZD...
November 27, 2016: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/27893418/high-risk-hpv-genotypes-and-p16ink4a-expression-in-a-cohort-of-head-and-neck-squamous-cell-carcinoma-patients-in-singapore
#16
Louise Soo Yee Tan, Petersson Fredrik, Liang Ker, Feng Gang Yu, De Yun Wang, Boon Cher Goh, Kwok Seng Loh, Chwee Ming Lim
Human papillomavirus (HPV), especially HPV16 genotype, is associated with oropharyngeal squamous cell carcinoma (OPSCC). We aim to determine the prevalence and characterize the high-risk (HR)-HPV genotypes in head and neck SCC (HNSCC) in a South-East Asian multi-ethnic society in Singapore and examine its prognostic significance.159 HNSCC archival tissue samples were retrieved and tumour DNA was screened for 18 HR-HPV genotypes using a PCR-based assay (Qiagen, digene HPV genotyping RH test). P16 protein overexpression was identified using immunohistochemistry (IHC)...
November 22, 2016: Oncotarget
https://www.readbyqxmd.com/read/27893042/androgen-deprivation-therapy-and-dose-escalated-radiotherapy-for-intermediate-and-high-risk-prostate-cancer-sign-of-changing-times
#17
Deepansh Dalela, Patrick Karabon, Firas Abdollah
No abstract text is available yet for this article.
November 23, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27893038/targeting-the-pi3k-akt-mtor-pathway-for-the-treatment-of-mesenchymal-triple-negative-breast-cancer-evidence-from-a-phase-1-trial-of-mtor-inhibition-in-combination-with-liposomal-doxorubicin-and-bevacizumab
#18
Reva K Basho, Michael Gilcrease, Rashmi K Murthy, Thorunn Helgason, Daniel D Karp, Funda Meric-Bernstam, Kenneth R Hess, Shelley M Herbrich, Vicente Valero, Constance Albarracin, Jennifer K Litton, Mariana Chavez-MacGregor, Nuhad K Ibrahim, James L Murray, Kimberly B Koenig, David Hong, Vivek Subbiah, Razelle Kurzrock, Filip Janku, Stacy L Moulder
Importance: Triple-negative breast cancer (TNBC) classified by transcriptional profiling as the mesenchymal subtype frequently harbors aberrations in the phosphoinositide 3-kinase (PI3K) pathway, raising the possibility of targeting this pathway to enhance chemotherapy response. Up to 30% of mesenchymal TNBC can be classified histologically as metaplastic breast cancer, a chemorefractory group of tumors with a mixture of epithelial and mesenchymal components identifiable by light microscopy...
November 23, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27893029/androgen-deprivation-therapy-and-dose-escalated-radiotherapy-for-intermediate-and-high-risk-prostate-cancer-reply
#19
Aaron D Falchook, Ramsankar Basak, Ronald C Chen
No abstract text is available yet for this article.
November 23, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27890073/switching-to-nilotinib-versus-imatinib-dose-escalation-in-patients-with-chronic-myeloid-leukaemia-in-chronic-phase-with-suboptimal-response-to-imatinib-lasor-a-randomised-open-label-trial
#20
Jorge E Cortes, Carmino Antonio De Souza, Manuel Ayala, Jose Luis Lopez, Eduardo Bullorsky, Sandip Shah, Xiaojun Huang, K Govind Babu, Kudrat Abdulkadyrov, José Salvador Rodrigues de Oliveira, Zhi-Xiang Shen, Tomasz Sacha, Israel Bendit, Zhizhou Liang, Tina Owugah, Tomasz Szczudlo, Sadhvi Khanna, Rafik Fellague-Chebra, Philipp D le Coutre
BACKGROUND: Optimal management of patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response remains undetermined. This study aimed to investigate the safety and efficacy of switching to nilotinib vs imatinib dose escalation for patients with suboptimal cytogenetic response on imatinib. METHODS: We did a phase 3, open-label, randomised trial in patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response to imatinib according to the 2009 European LeukemiaNet criteria, in Latin America, Europe, and Asia (59 hospitals and care centres in 12 countries)...
December 2016: Lancet Haematology
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