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Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations (MACS1148)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131325
First Posted: May 26, 2010
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
May 25, 2010
May 26, 2010
October 8, 2015
October 2010
August 2011   (Final data collection date for primary outcome measure)
To determine the number of ELN-guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations (<850 ng/mL) treated with nilotinib. [ Time Frame: up to 2 years ]
Same as current
Complete list of historical versions of study NCT01131325 on ClinicalTrials.gov Archive Site
  • To determine the proportion of ELN-defined optimal responses on nilotinib. [ Time Frame: up to 2 years ]
  • To determine the rate and time to loss of CCyR, MMR and CMR on nilotinib. [ Time Frame: up to 2 years ]
  • To determine the time to and duration of the CCyR, MMR and CMR achieved on nilotinib. [ Time Frame: up to 2 years ]
  • To determine EFS, PFS and OS with up to 2 years of nilotinib treatment and overall safety profile [ Time Frame: up to 2 years ]
Same as current
Not Provided
Not Provided
 
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • CML
  • Philadelphia Chromosome Positive (Ph+)
  • Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
Drug: nilotinib
All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours
Other Names:
  • AMN107
  • Tasigna
Experimental: Nilotinib
Intervention: Drug: nilotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ph+ CML-CP within 12 months of diagnosis
  • Imatinib 400 mg qd for up to 12 months
  • Imatinib trough plasma concentration <850 ng/mL
  • Patient that have met response milestones including:

    1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis
    2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%)
    3. CCyR at 12 months from diagnosis

Exclusion Criteria:

  • Prior documented failure events including:
  • Loss of CHR or CCyR
  • Less than CHR (stable disease or disease progression) at 3 months after diagnosis
  • No CyR at 6 months after diagnosis
  • Less than PCyR at 12 months after diagnosis
  • Prior accelerated phase or blast phase CML
  • Previously documented T315I mutation
  • Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
  • Patients who had any other treatment for CML (transplant) except imatinib, hydroxyurea and/or anagrelide
  • Impaired cardiac function (refer to Section 5.2 for details)
  • Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
  • Any other malignancy that is clinically significant or requires active intervention.
  • Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery.
  • Treatment with other investigational agents within 30 days of Day 1.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01131325
CAMN107AUS20
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP