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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive Bay 43-9006 400 mg po twice daily in a continuous, uninterrupted schedule. Treatment will continue until there is objective evidence of disease progression, or until evidence of toxicities that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Lyon, France
Unnamed facility
Paris, France
Unnamed facility
Poitiers, France
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.
Time frame: Every 3 months
To determine the cytogenetic response rate associated with BAY 43-9006.
Time frame: Every 3 months
To evaluate the duration of hematologic response to BAY 43-9006.
Time frame: Throughout study until end of response
To evaluate the duration of cytogenetic response to BAY 43-9006.
Time frame: Throughout study until end of response
To assess time to progression.
Time frame: Until event occurs
To assess overall survival..
Time frame: During Follow up
To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6
Time frame: At 2 months and at last visit
To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.
Time frame: Ongoing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.