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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00661180

First received: April 15, 2008

Last updated: April 13, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

April 13, 2010

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine the major hematologic response rate (i.e. complete and partial hematologic responses, as defined in section 4.6.1) associated with BAY 43-9006 in patients with chronic phase CML resistant to Gleevec. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00661180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Myelogenous Leukemia

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Nexavar (Sorafenib, BAY43-9006)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France

Administrative Information

NCT Number ^ICMJE

NCT00661180

Other Study ID Numbers ^ICMJE

10941

Has Data Monitoring Committee

Not Provided

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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