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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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