A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)
Phase 1/Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Both
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Trial Information
A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)
Inclusion Criteria:
- Patients who complete CAMN107A1101 and obtained Informed concent by document
Exclusion Criteria:
- None
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Adverse Events
Outcome Time Frame:
3 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CAMN107A1101E1
NCT ID:
NCT01279473
Start Date:
August 2005
Completion Date:
Related Keywords:
- Chronic Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- CML
- Acute Lymphoblastic Leukemia
- Philadelphia Chromosome Positive, ph+ ALL
- Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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