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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 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…

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 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…

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…

Dipeptidylpeptidase IV (CD26) on Philadelphia-positive leukemic stem cells (LSC) as marker and novel therapeutic target in chronic myeloid leukemia (CML).

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…

The Drug Rediscovery Protocol (DRUP trial)
A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile

This study has been transitioned to CTIS with ID 2023-509152-33-00 check the CTIS register for the current data. Primary Objectives• To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for…