check_circleStudy Completed
Chronic Myelogenous Leukemia
Bayer Identifier:
10941
ClinicalTrials.gov Identifier:
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
BothAge
18 YearsTrial summary
Enrollment Goal
10Trial Dates
January 2004 - February 2005Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere 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Withdrawn | PESSAC, 33600, France | |
Withdrawn | Los Angeles, 90024, United States |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.date_rangeTime Frame:Every 3 monthsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- To determine the cytogenetic response rate associated with BAY 43-9006.date_rangeTime Frame:Every 3 monthsenhanced_encryptionnoSafety Issue:
- To evaluate the duration of hematologic response to BAY 43-9006.date_rangeTime Frame:Throughout study until end of responseenhanced_encryptionnoSafety Issue:
- To evaluate the duration of cytogenetic response to BAY 43-9006.date_rangeTime Frame:Throughout study until end of responseenhanced_encryptionnoSafety Issue:
- To assess time to progression.date_rangeTime Frame:Until event occursenhanced_encryptionnoSafety Issue:
- To assess overall survival..date_rangeTime Frame:During Follow upenhanced_encryptionyesSafety Issue:
- To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6date_rangeTime Frame:At 2 months and at last visitenhanced_encryptionnoSafety Issue:
- To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.date_rangeTime Frame:Ongoingenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1