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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00661180

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

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that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.

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that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.

Outcome Measures

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. [Every 3 months]

Secondary Outcome Measures

To determine the cytogenetic response rate associated with BAY 43-9006. [Every 3 months]
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 time to progression. [Until event occurs]
To assess overall survival.. [During Follow up]
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 assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec. [Ongoing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Portland	Oregon	United States	97239
2	Lyon Cedex		France	69437
3	Paris		France	75010
4	Poitiers Cedex		France	86021

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00661180

Other Study ID Numbers:

10941
NCT00085007

First Posted:

Apr 18, 2008

Last Update Posted:

Dec 23, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Sorafenib

Study Results

No Results Posted as of Dec 23, 2014