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
Phase of Trial: Phase I
Latest Information Update: 20 Nov 2017
At a glance
- Drugs Nilotinib (Primary)
- Indications Acute lymphoblastic leukaemia; Chronic myeloid leukaemia
- Focus Pharmacokinetics
- Sponsors Novartis
- 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.