or
forgot password

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
Not Enrolling
Both
Leukemia, Myeloid

Thank you

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

Name

Location