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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site PARIS, France, 75010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site POITIERS, France, 86021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- 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 Outcome
- To determine the cytogenetic response rate associated with BAY 43-9006.Timeframe: Every 3 months
- To evaluate the duration of hematologic response to BAY 43-9006.Timeframe: Throughout study until end of response
- To evaluate the duration of cytogenetic response to BAY 43-9006.Timeframe: Throughout study until end of response
- To assess time to progression.Timeframe: Until event occurs
- To assess overall survival..Timeframe: During Follow up
- To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6Timeframe: At 2 months and at last visit
- To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.Timeframe: Ongoing
Additional Information
Copyright © Bayer
Powered by
