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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 )
  Purpose
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.

Condition Intervention Phase
CML Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels Drug: nilotinib Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: nilotinib
All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours
Other Names:
  • AMN107
  • Tasigna

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131325


Locations
United States, Nevada
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Las Vegas, Nevada, United States, 89109
United States, Texas
Cancer Center of the High Plains
Amarillo, Texas, United States, 79106
Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2)
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01131325     History of Changes
Other Study ID Numbers: CAMN107AUS20
First Submitted: May 25, 2010
First Posted: May 26, 2010
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Philadelphia chromosome positive
Ph+
chronic myelogenous leukemia chronic phase
CML-CP
low imatinib trough levels

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action