Expanded Access Program of Ponatinib

February 5, 2018 updated by: Ariad Pharmaceuticals

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center, Site #165
      • San Marcos, California, United States, 92069
        • Southern California Permanente Medical Group, Site #161
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center, Site #158
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale New Haven, Site #182
    • Florida
      • Altamonte Springs, Florida, United States, 32792
        • Cancer Institute of Florida, Site #187
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute, Site #017
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University, Site # 058
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center, Site #001
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transplantation, Site #138
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute, Site #142
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Site #040
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center, Site #141
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute, Site 008
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Worcester, Site #152
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System, Site #011
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute, Site #034
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Site #044
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Freeman Cancer Institute, Site #190
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Site 007
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center, Site 128
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute, Site #029
      • New York, New York, United States, 10065
        • Weill Cornell Medical College - New York Presbyterian Hospital, Site #006
      • Rochester, New York, United States, 14627
        • University of Rochester, Site 137
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center, Site 003
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Jewish Hospital, Site #175
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU), Site 048
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania, Site #013
      • Philadelphia, Pennsylvania, United States, 19111
        • Jeanes Hospital of TUHS, Site #127
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina, Site #148
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennesse Oncology, PLLC, Site # 076
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center, Site #005
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at the University of Utah, Site #043
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance, Site #100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ariad Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP24534-12-901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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