Yükleniyor... / Loading...
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
Bu çalışma, Philadelphia kromozomu pozitif (Ph+) Kronik Miyeloid Lösemi (CML) veya Akut Lenfoblastik Lösemi (ALL) olan çocuk hastalarda Nilotinib ilacının vücuttaki davranışını (farmakokinetik) inceliyor. Yeni tanılı ya da imatinib/dasatinibe dirençli çocuk hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy * adequate renal, hepatic and pancreatic function Exclusion Criteria: * patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug * patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. * gastrointestinal impairment or disease that may interfere with drug absorption * liver, pancreatic or severe renal disease unrelated to disease under study * impaired cardiac function * patients who received dasatinib within 3 days of starting study drug * patients who received imatinib within 5 days of starting study drug * patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib * patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug * patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and \< 3 months since SCT Other protocol-defined inclusion/exclusion criteria may apply