Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological Malignancies
|ClinicalTrials.gov Identifier: NCT00660920|
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia Hematologic Malignancies||Drug: Ponatinib||Phase 1|
An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose of Oral AP24534 in Patients With Refractory or Advanced Chronic Myelogenous Leukemia and Other Hematologic Malignancies|
|Actual Study Start Date :||June 2008|
|Primary Completion Date :||May 2016|
|Study Completion Date :||May 2016|
Comparison of different dosages of ponatinib given orally once per day.
Comparison of different dosages of drug given orally once per day.
- Determine Maximum Tolerated Dose (MTD) or Recommended dose [ Time Frame: Up to ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660920
|United States, California|
|ARIAD Investigational Site #075|
|San Francisco, California, United States, 94143|
|United States, Michigan|
|ARIAD Investigational Site #011|
|Ann Arbor, Michigan, United States, 48109|
|United States, Oregon|
|ARIAD Investigational Site #048|
|Portland, Oregon, United States, 97239|
|United States, Tennessee|
|ARIAD Investigational Site #076|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|ARIAD Investigational Site #005|
|Houston, Texas, United States, 70030|