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
Phase 1/Phase 2
55 Years
75 Years
55 Years
75 Years
Not Enrolling
Both
Leukemia, Myeloid
Both
Leukemia, Myeloid
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
KAN-979-01
NCT ID:
NCT00129168
Start Date:
August 2005
Completion Date:
March 2008
Related Keywords:
- Leukemia, Myeloid
- Leukemia, Myeloid
- Relapse
- Chemotherapy
- Zosuquidar
- Daunorubicin
- Cytarabine
- Acute
- AML
- Adult AML
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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