Trial Condition(s):

Chronic Myelogenous Leukemia

Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) patients resistant to Gleevec (ORACLE)

Bayer Identifier:

10941

ClinicalTrials.gov Identifier:

NCT00661180

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
10
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Investigative Site

PARIS, France, 75010

Locations

Investigative Site

Portland, United States, 97239

Locations

Investigative Site

LYON CEDEX, France, 69437

Locations

Investigative Site

POITIERS, France, 86021

Trial Design