Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of KW-2449 in Acute Leukemias (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelogenous Leukemia (CML)
This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute
leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an
18-month period, the investigative sites collectively will enroll up to a total of 96
subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2
dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period
as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm
B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by
recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose
level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects
in the same dose level in Arm B (28-day dosing regimen).
In April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing).
The protocol will continue as planned for Arm A (14 days of consecutive dosing).
Enrollment will proceed until a maximum tolerated dose (MTD) has been established for each
study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the
hematologic conditions included in this study, may be enrolled at the MTD as an expanded
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine maximum tolerated dose of KW-2449 using prespecified dose limiting toxicity definitions based on CTCAE, version 3.0 and to assess tolerability based on adverse events
For duration of dosing
Matt Fujimori, MD
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
|M.D. Anderson Cancer Center||Houston, Texas 77030|
|Johns Hopkins Hospital||Baltimore, Maryland 21287|
|Contact Kyowa||Princeton, New Jersey 08540|
|Weill Cornell/New York Presbyterian Hospital||New York, New York 10021|