25 results
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…
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…
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 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…
To measure the pharmacodynamic interaction between naproxen + acetylsalicylic acid as compared to the placebo + acetylsalicylic interaction. Also the pharmacodynamic interaction between acetylsalicylic acid and other in The Netherlands often used…
To investigate the postoperative pain, compliance, satisfaction in the three different groups of postoperative analgesia and a possible interaction.
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
The objective of this study is to determine the efficacy, safety, and tolerability of tafamidis in subjects with transthyretin cardiomyopathy.The primary objective is to assess the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg…
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
To obtain additional, long term, safety data for tafamidis in subjects with transthyretin amyloid cardiomyopathy (ATTR CM). To provide investigational product, tafamidis, to ATTR CM subjects who complete 30 months of blinded treatment on protocol…
Progression free survival
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.
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…