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Sponsored by: |
Kanisa Pharmaceuticals |
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Information provided by: | Kanisa Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00129168 |
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.
Condition | Intervention | Phase |
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Leukemia, Myeloid |
Drug: Zosuquidar Drug: Daunorubicin Drug: Cytarabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | August 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
For Phase II:
Study ID Numbers: | KAN-979-01 |
Study First Received: | August 9, 2005 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00129168 |
Health Authority: | United States: Food and Drug Administration |
Leukemia, Myeloid Relapse Chemotherapy Zosuquidar Daunorubicin |
Cytarabine Acute AML Adult AML Acute |
Daunorubicin Leukemia Acute myelogenous leukemia Acute myeloid leukemia, adult |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |