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: 02 Mar 2016

At a glance

  • Drugs Nilotinib (Primary)
  • Indications Acute lymphoblastic leukaemia; Chronic myeloid leukaemia
  • Focus Pharmacokinetics
  • Sponsors Novartis
  • Most Recent Events

    • 07 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.
    • 03 Aug 2015 Status changed from recruiting to completed, as reported by ClinicalTrials.gov.
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