Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01279473
Collaborator
(none)
42
1
1
Study Details
Study Description
Brief Summary
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date
:
Aug 1, 2005
Actual Primary Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nilotinib
|
Drug: Nilotinib
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [3 weeks]
Secondary Outcome Measures
- Best hematologic response rate and Best cytogenetic response rate. [3 years]
- Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL [3 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who complete CAMN107A1101 and obtained Informed concent by document
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Aichi | Japan |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01279473
Other Study ID Numbers:
- CAMN107A1101E1
- TAS-3-01
First Posted:
Jan 19, 2011
Last Update Posted:
Dec 8, 2020
Last Verified:
Aug 1, 2011
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: