Status:
COMPLETED
Efficacy and Safety of Nilotinib in CML-CP
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia, Chronic Phase
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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-outco...
Detailed Description
Nilotinib is a second-generation tyrosine kinase inhibitor with improved efficacy compared to imatinib. However, there are still many patients for whom the therapeutic response is inadequate, or toxic...
Eligibility Criteria
Inclusion
- Aged 19 or older
- Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase
Exclusion
- 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
Key Trial Info
Start Date :
May 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03332511
Start Date
May 6 2013
End Date
October 24 2016
Last Update
November 6 2017
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