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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00661180
First received: April 15, 2008
Last updated: October 9, 2013
Last verified: October 2013

April 15, 2008
October 9, 2013
January 2004
February 2005   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00661180 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
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.
Experimental: Arm 1
Intervention: Drug: Nexavar (Sorafenib, BAY43-9006)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2005
February 2005   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00661180
10941
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

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