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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01131325
First received: May 25, 2010
Last updated: April 2, 2014
Last verified: April 2014

May 25, 2010
April 2, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • To determine the rate and time to loss of CCyR, MMR and CMR on nilotinib. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • To determine the time to and duration of the CCyR, MMR and CMR achieved on nilotinib. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • To determine EFS, PFS and OS with up to 2 years of nilotinib treatment and overall safety profile [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01131325
CAMN107AUS20
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

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