Clinical Trials Directory

Trials / Completed

CompletedNCT01368523

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGnilotinib

Timeline

Start date
2008-12-01
Primary completion
2010-01-01
First posted
2011-06-08
Last updated
2016-11-16

Locations

3 sites across 1 country: Poland

Source: ClinicalTrials.gov record NCT01368523. Inclusion in this directory is not an endorsement.

Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in (NCT01368523) · Clinical Trials Directory