23 results
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
Primary:- To determine the MTD and/or a recommended phase II dose (RP2D) of BYL719 when administered orally in combination with imatinib 400 mg q.d.Secondary:- Assess the safety and tolerability profile of imatinib and BYL719 administered in…
To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…
To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping…
Primary:* Determine the maximum tolerated dose (MTD) and/or a recommended Phase II dose (RP2D) of BKM120 when administered in combination with imatinib 400 mg q.d.Secondary:* Assess the safety and tolerability profile of imatinib and BKM120…
1) Formulating a dose regimen for intravenous infusion of amoxicillin 1) More insight into the pharmacokinetics of amoxicillin in children of ages making more specific dosing possible.
Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid secretion might be causing the decreased exposure in the patients that underwent major gastrectomy. Therefore we would like to study if the exposure to imatinib in…
To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib versus imatinib
To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.
The main objective is to study the effects of targeted PDGFR and cKIT signalling inhibition with imatinib on gene expression profiles of colon tumours with a high chance of having the mesenchymal phenotype.
Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…
Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…
The current study aims to investigate the safety and effectiveness of imatinib mesilate solution for direct intravenous (iv) injection in mechanically-ventilated patients with COVID-19-related ARDS, where oral administration is probably ineffective…
Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…
REMAP-CAP: The goal of the study is to investigate the best treatment regime for pneumonia patients. For non-pandemic pneumonia (including Influenza) we investigate this in critically ill patients. For pneumonia caused by SARS-CoV-2, we investigate…
The objective of the study is to establish the long-term safety and tolerability of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed.
The primary objective is reducing treatment-related morbidity and mortality without adversely impacting DFS in Ph+ ALL patients, classified as Standard Risk (SR) based on low minimal residual disease (MRD) at week 10-12 of therapy.Because there is…