check_circleStudy 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
  • - 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.
  • - 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
10
Trial Dates
January 2004 - February 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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Withdrawn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Withdrawn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.
    date_rangeTime Frame:
    Every 3 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • To determine the cytogenetic response rate associated with BAY 43-9006.
    date_rangeTime Frame:
    Every 3 months
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate the duration of hematologic response to BAY 43-9006.
    date_rangeTime Frame:
    Throughout study until end of response
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate the duration of cytogenetic response to BAY 43-9006.
    date_rangeTime Frame:
    Throughout study until end of response
    enhanced_encryption
    Safety Issue:
    no
  • To assess time to progression.
    date_rangeTime Frame:
    Until event occurs
    enhanced_encryption
    Safety Issue:
    no
  • To assess overall survival..
    date_rangeTime Frame:
    During Follow up
    enhanced_encryption
    Safety Issue:
    yes
  • To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6
    date_rangeTime Frame:
    At 2 months and at last visit
    enhanced_encryption
    Safety Issue:
    no
  • To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.
    date_rangeTime Frame:
    Ongoing
    enhanced_encryption
    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
1

Additional Information

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