Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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ponatinib
Patients will receive ponatinib 45 mg orally as a single dose once daily with or without food. Each patient will receive daily ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must be ≥ 18 years old.
3. Provide written informed consent.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Men and women of childbearing potential must agree to effective contraception from the time of signing informed consent through the Follow-up Visit, approximately 30 days after last dose of ponatinib.
Exclusion Criteria
2. Have not adequately recovered from AEs due to agents previously administered
3. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
4. Have previously been treated with ponatinib.
5. Have significant or active cardiovascular disease, specifically including, but not restricted to:
* Myocardial infarction within 3 months prior to first dose of ponatinib,
* History of clinically significant atrial arrhythmia or any ventricular arrhythmia,
* Unstable angina within 3 months prior to first dose of ponatinib,
* Congestive heart failure within 3 months prior to first dose of ponatinib.
6. Have abnormal QTcF (\> 450 ms for males or \> 470 ms for females)
7. Have a significant bleeding disorder unrelated to CML or Ph+ ALL.
8. Have a history of pancreatitis or alcohol abuse
9. Have elevated amylase or lipase (\> 1.5 x ULN for institution) at entry.
10. Have inadequate hepatic function or any of the following:
* Total bilirubin \> 1.5 x ULN for institution at entry
* Alanine aminotransferase and aspartate aminotransferase \> 2.5 x ULN for institution at entry
* Prothrombin time \>1.5 x ULN for institution at entry
11. Have inadequate renal function or serum creatinine \> 2.5 x ULN for institution at entry
12. Have uncontrolled hypertriglyceridemia or triglycerides \> 450 mg/dL at entry.
13. Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib.
14. Women who are pregnant or lactating.
15. Underwent major surgery within 14 days prior to the first dose of ponatinib.
16. Have ongoing or active infection (including known history of human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\]).
17. Suffer from any condition or illness that, in the opinion of the Investigator would compromise patient safety or interfere with the evaluation of the safety of the study drug.
18 Years
ALL
No
Sponsors
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Ariad Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Moores UCSD Cancer Center, Site #165
La Jolla, California, United States
Southern California Permanente Medical Group, Site #161
San Marcos, California, United States
Kaiser Permanente Medical Center, Site #158
Vallejo, California, United States
Smilow Cancer Hospital at Yale New Haven, Site #182
New Haven, Connecticut, United States
Cancer Institute of Florida, Site #187
Altamonte Springs, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Site #017
Tampa, Florida, United States
Emory University, Site # 058
Atlanta, Georgia, United States
University of Chicago Medical Center, Site #001
Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, Site #138
Indianapolis, Indiana, United States
Norton Cancer Institute, Site #142
Louisville, Kentucky, United States
University of Maryland, Site #040
Baltimore, Maryland, United States
Tufts Medical Center, Site #141
Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Site 008
Boston, Massachusetts, United States
University of Massachusetts Worcester, Site #152
Worcester, Massachusetts, United States
University of Michigan Health System, Site #011
Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Site #034
Detroit, Michigan, United States
Mayo Clinic, Site #044
Rochester, Minnesota, United States
Freeman Cancer Institute, Site #190
Joplin, Missouri, United States
Washington University School of Medicine, Site 007
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Site 128
Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Site #029
Buffalo, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital, Site #006
New York, New York, United States
University of Rochester, Site 137
Rochester, New York, United States
Duke University Medical Center, Site 003
Durham, North Carolina, United States
Jewish Hospital, Site #175
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU), Site 048
Portland, Oregon, United States
Hospital of the University of Pennsylvania, Site #013
Philadelphia, Pennsylvania, United States
Jeanes Hospital of TUHS, Site #127
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Site #148
Charleston, South Carolina, United States
Tennesse Oncology, PLLC, Site # 076
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center, Site #005
Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah, Site #043
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Site #100
Seattle, Washington, United States
Countries
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Other Identifiers
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AP24534-12-901
Identifier Type: -
Identifier Source: org_study_id
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