To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib

An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01223898

Enrollment

Registered

2010-10-19

Start date

2010-06-30

Completion date

2013-12-31

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

CML,, nilotinib,, midazolam

Brief summary

This study will evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam (as a sensitive CYP3A probe) in CML patients. The following extension study does evaluate the safety of nilotinib.

Interventions

DRUGTasigna

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with a cytopathologically confirmed diagnosis of Ph+ CML or Philadelphia chromosome- negative (Ph-) CML patients in accelerated or chronic phase who are resistant and/or intolerant against at least one prior therapy with a BCR-ABL tyrosine kinase inhibitor 2. Female or male ≥ 18 years of age 3. Patients who are nilotinib naïve at study entry, e.g. did not receive any nilotinib treatment prior to study 4. WHO Performance Status of ≤ 2

Exclusion criteria

1. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required). 2. Impaired cardiac function 3. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis. 4. Patients actively receiving therapy with the prohibited co-medications (CYP3A4 inhibitors or inducers, or CYP2C inducers) 5. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval 6. Treatment with immunotherapy or chemotherapy within 3 days (6 weeks for nitrosurea or mitomycin-C) prior to Day 1 or who have not recovered from side effects of such therapy. 7. Treatment with imatinib within 1 week prior to Day 1 or who have not recovered from side effects of such therapy. 8. Patients who have hypersensitivity to midazolam or related compounds Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam in CML patients.	2 weeks

Secondary

Measure	Time frame
evaluate the safety and tolerability of multiple doses of nilotinib when midazolam is co-administered orally in CML patients.	2 weeks
Monitoring of safety of nilotinib during the extension study phase.	12 months

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026