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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

NCT ID: NCT01223898

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Keywords

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CML, nilotinib, midazolam

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nilotinib

Group Type EXPERIMENTAL

Tasigna

Intervention Type DRUG

Interventions

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Tasigna

Intervention Type DRUG

Other Intervention Names

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AMN107

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Frankfurt/M, , Germany

Site Status

Novartis Investigative Site

Jena, , Germany

Site Status

Novartis Investigative Site

Mannheim, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Novartis Investigative Site

Glasgow, , United Kingdom

Site Status

Countries

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Italy Germany United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12976

Results for CAMN107A2128 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2009-009425-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAMN107A2128

Identifier Type: -

Identifier Source: org_study_id