Tasigna in Glivec-resistant or Intolerant Patients in CML
This study is currently recruiting participants.
Verified June 2011 by Novartis Korea Ltd.
Information provided by:
Novartis Korea Ltd.
First received: September 20, 2010
Last updated: June 19, 2011
Last verified: June 2011
The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase IV Study for Nilotinib in Patients With Imatinib-resistant or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase.
Primary Outcome Measures:
- Complete cytogenetic response (CCyR) rate [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- evaluation of safety by NCI-CTCAE version 3.0 [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
administration of nilotinib as 2nd line
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Cardiac dysfunction : LVEF <45% by echocardiography, using 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 baseline ECG (using the QTcF formula), Myocardial infarction within 12 months prior to starting study, Other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- Treatment with any CSGF within 1 week of Day 1 except Erythropoietin.
- History of non-compliance to medical regimens or inability to grant consent.
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- 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. See link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.. Novartis must be contacted if a patient needs to be started on any of these drugs during study treatment.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- patients who diagnosed HIV infection.
- patients who has hypersensitivity for nilotinib or its additives
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug (Please see http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm for a comprehensive list of agents that prolong the QT interval)
- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
- Patients with rare genetic disease such as galactose intolerance, moderate lactase deficiency or glocose-galactose absoption disorder
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206088
|St. Mary hospital, Catholic medical center
|Seoul, Korea, Republic of |
|Contact: Sahee Park 15881511 |
Novartis Korea Ltd.
No publications provided
||Hijung Cho, Medical advisor, Oncology, Novartis Korea, Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 20, 2010
||June 19, 2011
||Korea: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Bone Marrow Diseases