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NCT00538109 Clinical Trial

An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Leukemia, Myeloid, Chronic Clinical Trial

Official title:
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00538109
Other study ID # RAC #2071-008
Secondary ID
Status Completed
Phase N/A
First received October 1, 2007
Last updated December 15, 2015
Start date October 2007
Est. completion date October 2013

Study information
Verified date December 2015
Source King Faisal Specialist Hospital & Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Glivec®/Gleevec®
Chemotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
King Faisal Specialist Hospital & Research Center

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness overall No
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