Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Information source: Kanisa Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Myeloid
Intervention: Zosuquidar (Drug); Daunorubicin (Drug); Cytarabine (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Kanisa Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: August 2005
Ending date: March 2008
Last updated: March 28, 2008
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