Status:
COMPLETED
Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec
Lead Sponsor:
Bayer
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard me...
Eligibility Criteria
Inclusion
- Have Philadelphia chromosome positive chronic myelogenous leukemia (CML) in chronic phase, as per IBMTR criteria- Have documented hematologic resistance to Gleevec (Imatinib) following a prior hematologic response to Gleevec administered at doses of at least 400 mg/d for at least 3 months.- Have WBC \>20 x 109/L at study entry- Have an ECOG performance status. Status of 0, 1 or 2- Have an anticipated survival of at least 16 weeks.- Be able to comply with study procedures and follow-up examinations.- Signed informed consent must be obtained prior to any study specific procedures.
Exclusion
- Congestive heart failure \> class II as defined by the New York Heart Association Functional Classification (NYHA)- Cardiac arrhythmias requiring antiarrythmics (excluding beta blockers or digoxin)- Active coronary artery disease or ischemia- History of HIV infection or chronic hepatitis B or C - Active clinically serious infections (\> grade 2 NCI-CTC)- Patients with seizure disorder requiring anti-epileptic drugs- History of solid organ allograft
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00661180
Start Date
January 1 2004
End Date
February 1 2005
Last Update
December 23 2014
Active Locations (4)
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1
Portland, Oregon, United States, 97239
2
Lyon, France, 69437
3
Paris, France, 75010
4
Poitiers, France, 86021