25 results
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…
Primary: To characterize the PK of nilotinib in pediatric patients with newly diagnosed CP Ph+ CML, with CP or AP Ph+ CML resistant / intolerant to imatinib and/or dasatinib, or with Ph+ ALL refractory/relapsed.Secondary:• To assess the safety and…
To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients
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…
To assess the effect of switching CML patients, who have been treated with imatinib *2 years and who have stable detectable molecular residual disease above 0.01% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of…
Primary objective:* To assess the clinical efficacy of nilotinib, based on overall response rate (ORR), in thetreatment of c-Kit mutated melanoma in patients who have not received prior therapy withTKIs.Key secondary objectives:To assess the durable…
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 objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…
PRIMARY OBJECTIVEThe primary objective of the study will be to determine the efficacy of 12 weeks of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation…
The aim of the current study is to confirm the CMR rates of nilotinib in newly diagnosed CML-CP patients in a pan-European population using the EUTOS (*European Treatment and Outcome Study for CML*) standardised molecular laboratories. Secondary…
To evaluate the efficacy and safety of nilotinib in spondyloarthritis
Primary:To assess the tolerability of asciminib versus nilotinib with respect to the time to discontinuation of study treatment due to adverse event.Secondary:• Efficacy of asciminib versus nilotinib in terms of discontinuation due to lack of…
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…
The purpose of this study is to determine the safety and efficacy of Nilotinib and Vildagliptin as combination therapy in optimal dosage. In addition, it is investigated whether the addition of Vildagliptin to Nilotinib treatment causes the…
Primary Objectives• To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma or non-Hodgkin lymphoma that harbours a genomic…
Assessment of duration of MMR or better after stopping TKI therapy a second or third time in patients with at least three years prior TKI treatment comprising at least two years of nilotinib treatment and maintained stable MR4 for at least one year…
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 Objective:* Assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (18F) Injection PET myocardial perfusion imaging (MPI) in the detection of significant CAD, as defined by invasive coronary angiography (ICA), in…
Primary:• Phase I part: to define the recommended dose (RD) of nilotinib and vinblastine when used in combination• Phase II part: to evaluate the efficacy of vinblastine in combination with nilotinib (VINILO) at the RD, as compared to vinblastine…