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

Phase 2

Completed

• Conditions: Chronic Myelogenous Leukemia
• Interventions: Drug: Nexavar (Sorafenib, BAY43-9006)

• Registration Number: NCT00661180
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-18
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Nexavar (Sorafenib, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
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.	Every 3 months

Secondary Outcome Measures

Name	Time	Method
To assess time to progression.	Until event occurs
To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.	Ongoing
To determine the cytogenetic response rate associated with BAY 43-9006.	Every 3 months
To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6	At 2 months and at last visit
To evaluate the duration of hematologic response to BAY 43-9006.	Throughout study until end of response
To evaluate the duration of cytogenetic response to BAY 43-9006.	Throughout study until end of response
To assess overall survival..	During Follow up