Overview

Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec

Status:
Completed

Trial end date:
2005-02-01

Target enrollment:
0

Participant gender:
All

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 medication administered for these patients.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bayer

Treatments:

Imatinib Mesylate
Niacinamide
Sorafenib

Criteria

Inclusion Criteria:- 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
Criteria:- 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