Study Completed

Chronic Myelogenous Leukemia

Bayer Identifier:

10941

ClinicalTrials.gov Identifier:

NCT00661180

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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

January 2004 - February 2005

Phase

Phase 2

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		PARIS, 75010, France
Completed		Portland, 97239, United States
Completed		LYON CEDEX, 69437, France
Completed		POITIERS, 86021, France
Withdrawn		PESSAC, 33600, France
Withdrawn		Los Angeles, 90024, United States

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.
Time Frame:
Every 3 months
Safety Issue:
no

Secondary Outcome

To determine the cytogenetic response rate associated with BAY 43-9006.
Time Frame:
Every 3 months
Safety Issue:
no
To evaluate the duration of hematologic response to BAY 43-9006.
Time Frame:
Throughout study until end of response
Safety Issue:
no
To evaluate the duration of cytogenetic response to BAY 43-9006.
Time Frame:
Throughout study until end of response
Safety Issue:
no
To assess time to progression.
Time Frame:
Until event occurs
Safety Issue:
no
To assess overall survival..
Time Frame:
During Follow up
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
Safety Issue:
no
To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.
Time Frame:
Ongoing
Safety Issue:
yes

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

Additional Information

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