Back to resultsZosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Primary Purpose
Leukemia, Myeloid
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Zosuquidar
Daunorubicin
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid focused on measuring Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, Daunorubicin, Cytarabine, Acute, AML, Adult AML
Eligibility Criteria
Inclusion Criteria: Newly diagnosed acute myeloid leukemia Ages 55-75 years Exclusion Criteria: Acute promyelocytic leukemia (FAB M3) Patients must not have received prior chemotherapy for AML. Prior exposure to anthracycline Use of any investigational agent within 4 weeks prior to enrollment into the study For Phase II: Patients must be P-glycoprotein positive
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00129168
Brief Title
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Official Title
An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kanisa Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.
Detailed Description
Purpose:
Phase I:
To Evaluate the safety of different doses of zosuquidar.
Phase II:
This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid
Keywords
Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, Daunorubicin, Cytarabine, Acute, AML, Adult AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zosuquidar
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Type
Drug
Intervention Name(s)
Cytarabine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed acute myeloid leukemia
Ages 55-75 years
Exclusion Criteria:
Acute promyelocytic leukemia (FAB M3)
Patients must not have received prior chemotherapy for AML.
Prior exposure to anthracycline
Use of any investigational agent within 4 weeks prior to enrollment into the study
For Phase II:
Patients must be P-glycoprotein positive
12. IPD Sharing Statement
Learn more about this trial
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
We'll reach out to this number within 24 hrs