The purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral AP24534 in a defined schedule in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Comparison of different dosages of drug given orally once per day.
ARIAD Investigational Site #075
San Francisco, California, United States
ARIAD Investigational Site #011
Ann Arbor, Michigan, United States
ARIAD Investigational Site #048
Portland, Oregon, United States
ARIAD Investigational Site #076
Nashville, Tennessee, United States
Determine Maximum Tolerated Dose (MTD) or Recommended dose
Determine MTD dose or a recommended dose of oral ponatinib in a defined schedule (QD) in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
Time frame: Up to
To examine the safety of AP24534 in patients with resistant/refractory hematologic malignancies
Time frame: Up to 7 years
To describe the anti-tumor activity of AP24534 in patients with refractory hematologic malignancies
Time frame: Up to 7 years
To examine the pharmacokinetics of AP24534
Time frame: Up to 2 cycles (1 cycle = 28 days)
To examine pharmacodynamic activity of AP24534 in CML and Ph + ALL patients
Time frame: Up to 7 years
To describe potential pharmacogenomic markers of AP24534 anti-tumor activity
Time frame: Up to 7 years
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ARIAD Investigational Site #005
Houston, Texas, United States