Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01368523
First received: June 6, 2011
Last updated: September 20, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to provide patients with imatinib resistant/intolerant chronic myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib (AMN107) in Poland until such time as the treatment with this drug is financed by the National Health Found in Poland (via 'therapeutic program') or for a period of 18 months, whichever comes first.


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: nilotinib
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to ENACT (CAMN107A2109) Trial

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • hematologic response [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cytogenetic response [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: December 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib Drug: nilotinib
Other Name: AMN107

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in chronic phase, accelerated phase or in blast crisis patients previously enrolled to CAMN107A2109 trial in Poland and continuing the treatment with nilotinib at the time of enrollment for this trial.
  2. In the opinion of the investigators would benefit from the further treatment with nilotinib
  3. No evidence of extramedullary leukaemic involvement, with the exception of liver and spleen
  4. Males or females ≥18 years of age
  5. WHO Performance Status of ≤ 2
  6. QTc ≤ 450 msec on the average of three serial baseline ECG (using the QTcF formula).
  7. Patients must have the following laboratory values:

    • Potassium within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication
    • Total calcium (corrected for serum albumin) within normal limits or correctable with supplements
    • Magnesium within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication
    • Phosphorus ≥ LLN or correctable with supplements
    • ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumour
    • Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumour
    • Serum bilirubin ≤ 1.5 x ULN
    • Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
    • Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN
  8. Written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

  1. Known T315I mutations
  2. Impaired cardiac function including any one of the following:

    • LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram
    • Inability to determine the QT interval on ECG
    • Complete left bundle branch block
    • Use of a ventricular-paced pacemaker
    • Congenital long QT syndrome or a known family history of long QT syndrome
    • History of or presence of clinically significant ventricular or atrial tachyarrhythmias
    • Clinically significant resting brachycardia (< 50 beats per minute)
    • QTc > 450 msec on the average of three serial baseline ECG (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
    • History of clinically documented myocardial infarction
    • History of unstable angina (during the last 12 months)
    • Other clinically significant heart disease (e.g. congestive heart failure or uncontrolled hypertension).
  3. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required)
  4. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection)
  5. History of significant congenital or acquired bleeding disorder unrelated to cancer
  6. Previous radiotherapy to ≥ 25% of the bone marrow
  7. Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
  8. History of non-compliance to medical regimens or inability to grant consent
  9. Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  10. Patients actively receiving therapy with strong CYP3A4 inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug or who are within 5 half-lives of the last dose of this medication prior to starting study drug.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368523

Locations
Poland
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Poznan, Poland
Novartis Investigative Site
Warsaw, Poland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01368523     History of Changes
Other Study ID Numbers: CAMN107APL01, EUDRACT 2008-000755-10
Study First Received: June 6, 2011
Last Updated: September 20, 2011
Health Authority: Poland: Central Register of Clinical Trials (CEBK)

Keywords provided by Novartis:
Chronic Myelogenous Leukemia
chronic phase
accelerated phase
blastic phase
nilotinib

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014