Efficacy and Safety of Nilotinib in CML-CP

• Status: Completed
• Trial end date: 2016-10-24
• Target enrollment: 0
• Participant gender: All

Summary

ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily) and its exposure-outcome relationship, in adult patients diagnosed as Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Aged 19 or older

• Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase

Exclusion Criteria:

• CML with atypical BCR-ABL1 transcripts (transcripts other than e13a2 or e14a2)

• Eastern Cooperative Oncology Group performance status ≥ 3

• Cardiac abnormality including a corrected QT interval ≥ 480 milliseconds, complete left bundle branch block, permanent pacemaker implantation, congenital long QT syndrome, history of tachyarrhythmia requiring treatment, clinically significant resting bradycardia, history of acute coronary syndrome within 12 months, and decompensated congestive heart failure

• Organ dysfunction defined by total serum bilirubin levels ≥ 1.5 × the upper limit of the normal range (ULN), creatinine ≥ 1.5 × ULN, aspartate or alanine aminotransferase ≥ 2.5 × ULN, amylase or lipase ≥ 1.5 × ULN and alkaline phosphatase ≥ 2.5 × ULN not directly related to the CML

• Uncontrolled hypertension and/or diabetes

• Active and uncontrolled infection

• Major surgery within two weeks or incomplete recovery from the previous surgery

• Congenital or acquired bleeding tendency

• Impaired gastrointestinal absorption

• History of small bowel resection or bypass surgery

• History of acute pancreatitis within 12 months or chronic pancreatitis

• Concomitant administration of strong irreplaceable CYP3A4 inhibitors or inducers, QT-prolonging agents, or coumarin derivatives

• Any other uncontrolled medical conditions that would present substantial safety risks or compromise compliance with the study treatment