Expanded Access Program of Ponatinib



Status:Approved for marketing
Conditions:Other Indications, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/8/2018

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Expanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic
myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic
leukemia (Ph+ALL) who have failed all available treatment options.

This protocol will allow expanded access of ponatinib to patients ≥18 years with CML or
Ph+ALL who have failed all available treatment options. Patients with chronic (CP) or
accelerated phase (AP) CML must be previously treated with and resistant or intolerant to
imatinib, dasatinib and nilotinib or develop the T315I mutation after any tyrosine kinase
inhibitor (TKI) therapy. Patients with blast phase (BP) CML and Ph+ ALL must be previously
treated with and resistant or intolerant to imatinib and dasatinib or develop the T315I
mutation after any TKI therapy. No formal analysis will be performed on any data obtained.
Safety information will be collected and adverse events will be tabulated for reporting
purposes only.

Main Inclusion Criteria:

1. CP-CML and AP-CML patients previously treated with and resistant or intolerant to
imatinib, dasatinib and nilotinib or those who developed the T315I mutation after any
TKI therapy. BP-CML and Ph+ ALL patients previously treated with and resistant or
intolerant to imatinib and dasatinib or those who developed the T315I mutation after
any TKI therapy.

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.

Main Exclusion Criteria:

Patients are not eligible for participation in the study if they meet any of the following
exclusion criteria:

1. Are eligible for an ongoing and accessible clinical trial of ponatinib

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.
We found this trial at
33
sites
Joplin, Missouri 64804
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Vallejo, California 94589
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894 East Altamonte Drive
Altamonte Springs, Florida 32792
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cincinnati, Ohio 45236
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Detroit, Michigan 48201
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, IN
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La Jolla, California 92093
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Louisville, Kentucky 40207
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Nashville, Tennessee 37203
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New Haven, Connecticut 06520
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Philadelphia, Pennsylvania 19111
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Worcester, Massachusetts 01655
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