18 results
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…
Primary:To determine the response rate and response quality of dasatinib monotherapy or dasatinib/fludarabine combination in fludarabine refractory CLL patientsSecundaryTo asses the overall safety profile of this treatment approachTo asses event…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
Assessment of treatment-free remission (persistence of MMR) after second attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of…
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…
The general objectives are to assess the safety of combining dasatinib with CCNU as well as to assess activity of this combination and CCNU alone in GBM patients who have relapsed after prior treatment with temozolomide and radiotherapy
The objective of this study is to obtain information regarding the effectiveness and safety of a product called Foster® for the treatment of asthma. This product is a combination between two well known drugs: formoterol fumarate and beclomethasone…
The primary objective is to determine the safety and the maximum tolerated dose of dasatinib in combination with lenalidomide and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma
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 purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…
The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…
The main objective of this study is to estimate the rate of response to dasatinib in children and adolescents with certain types of Ph+ leukaemia either whose disease is resistant to, intolerant to or relapsed after previous imatinib therapy or are…
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.
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…
To examine the effect of oral dasatinib plus quercetin on liver fibrosis as assessed by histology in individuals with biopsy-proven NAFLD with fibrosis by performing a double*blind randomized controlled proof*of*principle study. The primary endpoint…
Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.
Primary Objective phase 1:- To determine the Recommended Phase 2 Dose (RP2D) of bosutinib for R/I (RP2DR/I) and ND chronic phase (RP2DND) pediatric patients withCML, based on the pharmacokinetic, safety and tolerability profile of bosutinib observed…
Primary:Determine the MTD and/or RDE(s) of ABL001:* As a single agent for CML CP and AP patients* In combination with either nilotinib or imatinib or dasatinib in CML CP and AP patients* As a single agent for CML BP patients and Ph+ ALL…