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

Chronic Myelogenous Leukemia Clinical Trial

— ORACLE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661180
• Other study ID #: 10941
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2008
• Last updated: December 18, 2014
• Start date: January 2004
• Est. completion date: February 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00085007

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the cytogenetic response rate associated with BAY 43-9006.		Every 3 months	No
Secondary	To evaluate the duration of hematologic response to BAY 43-9006.		Throughout study until end of response	No
Secondary	To evaluate the duration of cytogenetic response to BAY 43-9006.		Throughout study until end of response	No
Secondary	To assess time to progression.		Until event occurs	No
Secondary	To assess overall survival..		During Follow up	Yes
Secondary	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	No
Secondary	To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.		Ongoing	Yes

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