Clinical trial NCT00661180: Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec
Official title: Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myelogenous Leukemia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 medication administered for these patients.


Eligibility 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

Primary outcomes:
measure: To determine the major hematologic response rate (i.e. complete and partial hematologic responses) associated with BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.
timeFrame: Every 3 months
Secondary outcomes:
measure: To determine the cytogenetic response rate associated with BAY 43-9006.
timeFrame: Every 3 months
measure: To evaluate the duration of hematologic response to BAY 43-9006.
timeFrame: Throughout study until end of response
measure: To evaluate the duration of cytogenetic response to BAY 43-9006.
timeFrame: Throughout study until end of response
measure: To assess time to progression.
timeFrame: Until event occurs
measure: To assess overall survival..
timeFrame: During Follow up
measure: To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6
timeFrame: At 2 months and at last visit
measure: To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.
timeFrame: Ongoing
Other outcomes:
Locations:
city: Portland
country: United States
state: Oregon
city: Lyon Cedex
country: France
city: Paris
country: France
city: Poitiers Cedex
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: