An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given With High Dose Cytarabine and Mitoxantrone in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
PRIMARY OBJECTIVES:
I. To determine the safety and maximum tolerated dose (MTD) of CPI-613 when administered
with high dose cytarabine, and mitoxantrone (mitoxantrone hydrochloride).
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetics (PKs) of CPI-613 following intravenous (IV)
administration in combination with high dose cytarabine and mitoxantrone.
II. To observe the response rate (complete response [CR], complete response with incomplete
platelet recovery [CRi] and partial response [PR]) of CPI-613 in combination with high dose
cytarabine and mitoxantrone.
III. To observe the overall survival of patients treated with CPI-613 in combination with
high dose cytarabine and mitoxantrone.
OUTLINE: This is a dose-escalation study of CPI-613.
Patients receive CPI-613 intravenously (IV) over 2 hours on days 1-5, cytarabine IV over 3
hours every 12 hours for 5 doses beginning on day 3, and mitoxantrone hydrochloride IV over
15 minutes after the 1st, 3rd, and 5th doses of cytarabine. . Treatment repeats every 14
days for up to 2 courses* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients undergoing a second course of therapy receive CPI-613 IV over 2 hours on
days 1-3, cytarabine IV over 3 hours every 12 hours for 5 doses beginning on day 2, and
mitoxantrone hydrochloride IV over 15 minutes after the 1st and 3rd doses of cytarabine.
After completion of study treatment, patients are followed up for 6 months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of CPI-613 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0)
14 days
Yes
Timothy Pardee
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
CCCWFU 22112
NCT01768897
January 2013
Name | Location |
---|---|
Comprehensive Cancer Center of Wake Forest University | Winston-Salem, North Carolina 27157-1082 |