NCT01223898

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 9, 2020

Status Verified

April 1, 2016

Enrollment Period

3.5 years

First QC Date

October 18, 2010

Last Update Submit

December 6, 2020

Conditions

Chronic Myeloid Leukemia

Keywords

CML,nilotinib,midazolam

Outcome Measures

Primary Outcomes (1)

  • evaluate the effects of multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam in CML patients.

    2 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

Nilotinib

EXPERIMENTAL
Drug: Tasigna

Interventions

TasignaDRUG
Also known as: AMN107
Nilotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Female or male ≥ 18 years of age
  • Patients who are nilotinib naïve at study entry, e.g. did not receive any nilotinib treatment prior to study
  • WHO Performance Status of ≤ 2

You may not qualify if:

  • Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
  • Impaired cardiac function
  • History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
  • Patients actively receiving therapy with the prohibited co-medications (CYP3A4 inhibitors or inducers, or CYP2C inducers)
  • Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval
  • 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.
  • Treatment with imatinib within 1 week prior to Day 1 or who have not recovered from side effects of such therapy.
  • Patients who have hypersensitivity to midazolam or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Frankfurt/M, 60590, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Mannheim, 68167, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 9, 2020

Record last verified: 2016-04

Locations

DE(4)GB(1)