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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661180
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Drug: Nexavar (Sorafenib, BAY43-9006) Phase 2

Expanded Access : Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Arm Intervention/treatment
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
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that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the cytogenetic response rate associated with BAY 43-9006. [ Time Frame: Every 3 months ]
  2. To evaluate the duration of hematologic response to BAY 43-9006. [ Time Frame: Throughout study until end of response ]
  3. To evaluate the duration of cytogenetic response to BAY 43-9006. [ Time Frame: Throughout study until end of response ]
  4. To assess time to progression. [ Time Frame: Until event occurs ]
  5. To assess overall survival.. [ Time Frame: During Follow up ]
  6. 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 ]
  7. To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec. [ Time Frame: Ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661180

United States, Oregon
Portland, Oregon, United States, 97239
Lyon Cedex, France, 69437
Paris, France, 75010
Poitiers Cedex, France, 86021
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00661180     History of Changes
Obsolete Identifiers: NCT00085007
Other Study ID Numbers: 10941
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs