33 results
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…
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…
The purpose of this study is to determine whether optical mammography performed on the PMS DOT has a potential in breast cancer diagnosis in patients with suspicious breast lesions.
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.
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
This study will evaluate the efficacy and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis (RRMS).The objective of the Immune Substudy is to explore immunological changes associated with ocrelizumab treatment…
Primary:To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by thetime to onset of confirmed disability progression over the treatment period, defined as an increase…
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…
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…
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.
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…
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 an optimal dose of AV-101 based primarily upon the change in PVR but also other efficacy, safety, and tolerability findings from the Phase 2b Part of the study. The optimal dose will be taken into the Phase…
Progression free survival
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 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…
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
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…
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.
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…