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 and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

Trial Profile

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 and/or Dasatinib, or With Refractory/Relapsed Ph+ ALL

Completed
Phase of Trial: Phase I

Latest Information Update: 20 Nov 2017

At a glance

  • Drugs Nilotinib (Primary)
  • Indications Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Pharmacokinetics
  • Sponsors Novartis
  • Most Recent Events

    • 20 Nov 2017 According to a Novartis media release, based on the results from this trial, the European Commission (EC) approved Tasigna (nilotinib) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy.
    • 10 Jun 2017 Biomarkers information updated
    • 26 Jan 2016 No of arms changed from 3 to 2 with change in dose of 50-200 to 50-400mg as per ClinicalTrials.gov record.
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