10 results
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…
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.
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…
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…
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)…
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 objective is to determine the effect of Transvamix on the pain quality item *unpleasantness*, relative to placebo. Secondary objectives include the assessment of general pain qualities, pain self-efficacy, general pain and pruritus…
The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([11C]UCB-J PET), in vivo regional tau pathology ([18F]flortaucipir PET) and in vivo regional Aβ pathology ([18F]florbetapir PET).…
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…
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…