Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

Leukemia, Myeloid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129168
• Other study ID #: KAN-979-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 9, 2005
• Last updated: March 28, 2008
• Start date: August 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Kanisa Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Zosuquidar

• Daunorubicin

• Cytarabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kanisa Pharmaceuticals