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557 results for “Imatinib”
Article data of The Impact of MDR-1 Gene Polymorphism (rs1128503) on Response to Imatinib and nilotinib Treatment in A Sample of Iraqi Chronic Myeloid Leukemia-Chronic Phase Patients
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Elevated acute phase proteins affect pharmacokinetics in COVID-19 trials: Lessons from the CounterCOVID - imatinib study
<p>Abstract</p> <p>This study aimed to determine whether published pharmacokinetic (PK) models can adequately predict the PK profile of imatinib in a new indication, such as coronavirus disease 2019 (COVID-19). Total (bound + unbound) and unbound imatinib plasma concentrations obtained from 134 patients with COVID-19 participating in the CounterCovid study and from an historical dataset of 20 patients with gastrointestinal stromal tumor (GIST) and 85 patients with chronic myeloid leukemia (CML) were compared. Total imatinib area under the concentration time curve (AUC), maximum concentration (C<sub>max</sub>) and trough concentration (C<sub>trough</sub>) were 2.32-fold (95% confidence interval [CI] 1.34–3.29), 2.31-fold (95% CI 1.33–3.29), and 2.32-fold (95% CI 1.11–3.53) lower, respectively, for patients with CML/GIST compared with patients with COVID-19, whereas unbound concentrations were comparable among groups. Inclusion of alpha1-acid glycoprotein (AAG) concentrations measured in patients with COVID-19 into a previously published model developed to predict free imatinib concentrations in patients with GIST using total imatinib and plasma AAG concentration measurements (AAG-PK-Model) gave an estimated mean (SD) prediction error (PE) of −20% (31%) for total and −7.0% (56%) for unbound concentrations. Further covariate modeling with this combined dataset showed that in addition to AAG; age, bodyweight, albumin, CRP, and intensive care unit admission were predictive of total imatinib oral clearance. In conclusion, high total and unaltered unbound concentrations of imatinib in COVID-19 compared to CML/GIST were a result of variability in acute phase proteins. This is a textbook example of how failure to take into account differences in plasma protein binding and the unbound fraction when interpreting PK of highly protein bound drugs, such as imatinib, could lead to selection of a dose with suboptimal efficacy in patients with COVID-19.</p>
Pharmacokinetics and pharmacodynamics of imatinib for optimal drug repurposing from cancer to COVID-19
<p><strong>Introduction:</strong> In the randomized double-blind placebo-controlled CounterCOVID study, oral imatinib treatment<br> conferred a positive clinical outcome and a signal for reduced mortality in COVID-19 patients. High concen-<br> trations of alpha-1 acid glycoprotein (AAG) were observed in these patients and were associated with increased<br> total imatinib concentrations.<br> <strong>Aims:</strong> This post-hoc study aimed to compare the difference in exposure following oral imatinib administration in<br> COVID-19 patients to cancer patients and assess assocations between pharmacokinetic (PK) parameters and<br> pharmacodynamic (PD) outcomes of imatinib in COVID-19 patients. We hypothesize that a relatively higher drug<br> exposure of imatinib in severe COVID-19 patients leads to improved pharmacodynamic outcome parameters.<br> <strong>Methods:</strong> 648 total concentration plasma samples obtained from 168 COVID-19 patients were compared to 475<br> samples of 105 cancer patients, using an AAG-binding model. Total trough concentration at steady state (Cttrough)<br> and total average area under the concentration-time curve (AUCtave) were associated with ratio between partial<br> oxygen pressure and fraction of inspired oxygen (P/F), WHO ordinal scale (WHO-score) and liberation of oxygen<br> supplementation (O2lib). Linear regression, linear mixed effects models and time-to-event analysis were adjusted<br> for possible confounders.<br> <strong>Results:</strong> AUCtave and Cttrough were respectively 2.21-fold (95%CI 2.07–2.37) and 1.53-fold (95%CI 1.44–1.63)<br> lower for cancer compared to COVID-19 patients. Cttrough, not AUCtave, associated significantly with P/F<br> (β=-19,64; p-value=0.014) and O2lib (HR 0.78; p-value= 0.032), after adjusting for sex, age, neutrophil-<br> lymphocyte ratio, dexamethasone concomitant treatment, AAG and baseline P/F-and WHO-score. Cttrough, but<br> not AUCtave associated significantly with WHO-score. These results suggest an inverse relationship between PK-<br> parameters, Cttrough and AUCtave, and PD outcomes.<br> <strong>Conclusion:</strong> COVID-19 patients exhibit higher total imatinib exposure compared to cancer patients, attributed to<br> differences in plasma protein concentrations. Higher imatinib exposure in COVID-19 patients did not associate<br> with improved clinical outcomes. Cttrough and AUCtave inversely associated with some PD-outcomes, which may be biased by disease course, variability in metabolic rate and protein binding. Therefore, additional PKPD an-<br> alyses into unbound imatinib and its main metabolite may better explain exposure-response.</p>
Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
ClinicalTrials.gov study NCT00075400. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
ClinicalTrials.gov study NCT00049127. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
ClinicalTrials.gov study NCT01478373. IPD Sharing: Not stated. Countries: 5. Publications: 0.
Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov study NCT00323362. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
ClinicalTrials.gov study NCT00529763. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
ClinicalTrials.gov study NCT00613171. IPD Sharing: Not stated. Countries: 5. Publications: 0.
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
ClinicalTrials.gov study NCT00015847. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
ClinicalTrials.gov study NCT00793871. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer
ClinicalTrials.gov study NCT00323063. IPD Sharing: Not stated. Countries: 1. Publications: 0.
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
ClinicalTrials.gov study NCT00171249. IPD Sharing: Not stated. Countries: 5. Publications: 0.
Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib
ClinicalTrials.gov study NCT01660906. IPD Sharing: Not stated. Countries: 5. Publications: 0.
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
ClinicalTrials.gov study NCT00074308. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
ClinicalTrials.gov study NCT05557942. IPD Sharing: Not stated. Countries: 20. Publications: 0.
Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia
ClinicalTrials.gov study NCT02687425. IPD Sharing: UNDECIDED. Countries: 0. Publications: 1.
Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
ClinicalTrials.gov study NCT00702403. IPD Sharing: NO. Countries: 1. Publications: 0.
Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer
ClinicalTrials.gov study NCT00331409. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
ClinicalTrials.gov study NCT01795716. IPD Sharing: Not stated. Countries: 1. Publications: 0.
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