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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 15, 2008
Last updated: December 18, 2014
Last verified: December 2014
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 Intervention Phase
Chronic Myelogenous Leukemia
Drug: Nexavar (Sorafenib, BAY43-9006)
Phase 2

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the cytogenetic response rate associated with BAY 43-9006. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • To evaluate the duration of hematologic response to BAY 43-9006. [ Time Frame: Throughout study until end of response ] [ Designated as safety issue: No ]
  • To evaluate the duration of cytogenetic response to BAY 43-9006. [ Time Frame: Throughout study until end of response ] [ Designated as safety issue: No ]
  • To assess time to progression. [ Time Frame: Until event occurs ] [ Designated as safety issue: No ]
  • To assess overall survival.. [ Time Frame: During Follow up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00661180     History of Changes
Obsolete Identifiers: NCT00085007
Other Study ID Numbers: 10941 
Study First Received: April 15, 2008
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on February 11, 2016