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557 results for “imatinib”
Metabolic shift of chronic myeloid leukemia patients under Imatinib-Pioglitazone regimen and discontinuation_dataset
<p>The EDI-PIO (<strong>E</strong>studo de <strong>D</strong>escontinuação de <strong>I</strong>matinibe após<strong> Pio</strong>glitazona) is a single-center, longitudinal, prospective, phase 2, non-randomized, open, clinical trial (NCT02852486, August 2, 2016 retrospectively registered) for the discontinuation of imatinib after concomitant use of pioglitazone, being the first of its kind in a Brazilian population with chronic myeloid leukemia. Due to remaining of leukemic quiescent cells that are not affected by tyrosine kinase inhibitors, it has been suggested the use of pioglitazone, a PPARγ agonist, together with imatinib as a strategy for the maintenance of deep molecular response. The clinical benefit to this association is still controversial, and the metabolic alteration along this process remains unclear. Therefore, we applied a metabolomic protocol using high-resolution mass spectrometry to profile plasmatic metabolic response of a prospective cohort of 10 individuals under discontinuation of imatinib and pioglitazone protocol. By comparing patients under pioglitazone and imatinib treatment with imatinib monotherapy and discontinuation phase, we were able to annotate 41 and 36 metabolites, respectively. The metabolic alterations observed during Imatinib-Pioglitazone combined therapy are associated with an extensive lipid remodelling, with activation of β-oxidation pathway, in addition to the presence of markers that suggest mitochondrial dysfunction.</p>
Confirmation of the suitability and stability of the imatinib mesylate drug product formulation for intravenous administration in the INVENT-COVID clinical trial
<p>Abstract:</p> <p>An isotonic sterile aqueous solution of imatinib mesylate was formulated and then manufactured according to cGMP by KABS Laboratories. A solution pH of 5.0 is optimum for imatinib mesylate solubility and stability and this is maintained by a sodium acetate buffer. The drug product for the clinical study was presented as a sterile solution in a Type 1 clear glass vial with chlorobutyl stopper and seal. Stability studies on the drug product have confirmed an excellent stability profile and these data are presented in Table 1. The drug product specification detailed in this table is consistent with Regulatory Authority requirements for this stage in clinical development. These data support the conclusion that the drug product used in the INVENT-COVID trial was fully compliant with all cGMP and EU Regulatory Authority requirements.</p> <p> </p>
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
ClinicalTrials.gov study NCT03578367. IPD Sharing: YES. Countries: 15. Publications: 1.
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
ClinicalTrials.gov study NCT00471497. IPD Sharing: YES. Countries: 35. Publications: 8.
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
ClinicalTrials.gov study NCT03589326. IPD Sharing: YES. Countries: 20. Publications: 2.
Pharmacokinetic dataset of a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19
<p>Abstract</p> <p>Background</p> <p>The coronavirus disease 2019 (COVID-19) pandemic has led to a disruptive increase in the number of intensive care unit (ICU) admissions with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterized by widespread inflammation and vascular leak in the lungs. Although there is no proven therapy to reduce pulmonary vascular leak in ARDS, recent studies demonstrated that the tyrosine kinase inhibitor imatinib reinforces the endothelial barrier and prevents vascular leak in inflammatory conditions, while leaving the immune response intact.</p> <p>Methods</p> <p>This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trial of intravenous (IV) imatinib mesylate in 90 mechanically ventilated subjects with COVID-19-induced ARDS. Subjects are 18 years or older, admitted to the ICU for mechanical ventilation, meeting the Berlin criteria for moderate-severe ARDS with a positive polymerase chain reaction test for SARS-CoV2. Participants will be randomized in a 1:1 ratio to either imatinib (as mesylate) 200 mg bis in die (b.i.d.) or placebo IV infusion for 7 days, or until ICU discharge or death. The primary study outcome is the change in Extravascular Lung Water Index (EVLWi) between day 1 and day 4. Secondary outcome parameters include changes in oxygenation and ventilation parameters, duration of invasive mechanical ventilation, number of ventilator-free days during the 28-day study period, length of ICU stay, and mortality during 28 days after randomization. Additional secondary parameters include safety, tolerability, and pharmacokinetics.</p> <p>Discussion</p> <p>The current study aims to investigate the efficacy and safety of IV imatinib in mechanically ventilated subjects with COVID-19-related ARDS. We hypothesize that imatinib decreases pulmonary edema, as measured by extravascular lung water using a PiCCO catheter. The reduction in pulmonary edema may reverse hypoxemic respiratory failure and hasten recovery. As pulmonary edema is an important contributor to ARDS, we further hypothesize that imatinib reduces disease severity, reflected by a reduction in 28-day mortality, duration of mechanical ventilation, and ICU length of stay.</p>
Original dataset for the species sensitivity distribution (SSD) curves of the antineoplastics Imatinib, Cisplatin and 5-Fluorouracil
<p>Original dataset (LC<sub>50</sub> and EC<sub>50</sub> for freshwater species) for the species sensitivity distribution (SSD) curves of the antineoplastics Imatinib (IM), Cisplatin (CisPt) and 5-Fluorouracil (5-FU).</p>
Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
ClinicalTrials.gov study NCT00028002. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Trial of Imatinib for Hospitalized Adults With COVID-19
ClinicalTrials.gov study NCT04394416. IPD Sharing: NO. Countries: 1. Publications: 39.
Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
ClinicalTrials.gov study NCT00470470. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT
ClinicalTrials.gov study NCT01151852. IPD Sharing: Not stated. Countries: 1. Publications: 9.
Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov study NCT01392495. IPD Sharing: Not stated. Countries: 7. Publications: 2.
Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
ClinicalTrials.gov study NCT00101816. IPD Sharing: Not stated. Countries: 20. Publications: 2.
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
ClinicalTrials.gov study NCT00644878. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients
ClinicalTrials.gov study NCT01275196. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Per
ClinicalTrials.gov study NCT00760877. IPD Sharing: Not stated. Countries: 6. Publications: 1.
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
ClinicalTrials.gov study NCT00574873. IPD Sharing: YES. Countries: 29. Publications: 7.
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
ClinicalTrials.gov study NCT00777036. IPD Sharing: Not stated. Countries: 18. Publications: 1.
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
ClinicalTrials.gov study NCT00101660. IPD Sharing: Not stated. Countries: 22. Publications: 2.
Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer
ClinicalTrials.gov study NCT00161213. IPD Sharing: NO. Countries: 1. Publications: 1.
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