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Phase II study of nilotinib efficacy in pigmented villo-nodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT)

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…

Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase

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…

A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

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…

A multi-center, open-label, pharmacokinetic study of oral nilotinib in pedriatric patients with Gleevec (imatinib)-resistant/intolerant Ph+ CML chronic phase (CP) or accelerated phase (AP) or with refractory/relapsed Ph+ ALL.;Met protocol amendment #03 verandert de titel als volgt:
*A multi-center, open-label, pharmacokinetic study of oral nilotinib in pediatric patients with newly diagnosed chronic phase (CP) Ph+ CML, with CP or accelerated phase (AP) Ph+ CML resistant/intolerant to imatinib

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…

A Phase II, single arm, open label study of treatment-free remission in chronic myeloid leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on Nilotinib

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…

A Single arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment

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 TEAM trial (Tasigna efficacy in advanced melanoma): A
phase II, open label, multi-center, single-arm study to
assess the efficacy of Tasigna® in the treatment of patients
with metastatic and/or inoperable melanoma harboring a c-
Kit mutation

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…

A randomized, open-label, multi-center study to evaluate the efficacy of nilotinib versus best supportive care with or without a tyrosine kinase inhibitor (investigator's choice) in adult patients with gastrointestinal stromal tumors resistant to both imatinib and sunitinib.

Primary* To evaluate whether the efficacy of nilotinib is superior to the control arm (as measured by progression free survivalSecondary* To compare the response rate, and time to response, duration of response, and time to tumor progression of…

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation

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…

A phase III randomized, open-label, multi-center study of nilotinib versus imatinib in adult patients with philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) ib unatubub

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.

A phase II, single arm, multicenter study of nilotinib in combination with pegylated interferon *2b in patients with suboptimal molecular response or stable detectable molecular residual disease after at least two years of imatinib treatment (NordDutchCML009)

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…

Effect of food on the pharmacokinetics of nilotinib in chronic myeloid leukemia: assessment of a tailored dose reduction (NiFo-study)

To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients

A phase III multi-center, open label, randomised study of optimised imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

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…

NAUT study: Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping TKI 2nd time or 3rd time

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…

PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

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…

An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment

The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment…

A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

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…

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study

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.

SUSTRENIM - GIMEMA CML1415 / HOVON 142 CML

This study has been transitioned to CTIS with ID 2023-510434-83-00 check the CTIS register for the current data. The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in…