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Compassionate Use Ponatinib

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ClinicalTrials.gov Identifier: NCT01549548
Expanded Access Status : No longer available
First Posted : March 9, 2012
Last Update Posted : March 15, 2013
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Study Description
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Brief Summary:
The main purpose of this protocol is to provide expanded access to the study drug (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that have not responded to prior treatment.

Condition or disease Intervention/treatment
Philadelphia Chromosome Positive (Ph+) Leukemias Chronic Myeloid Leukemia Drug: Ponatinib

Study Design
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Study Type : Expanded Access
Official Title: Treatment Plan for the Compassionate Use of Ponatinib (AP24534) in Patients With Imatinib-, Dasatinib-, and Nilotinib- Resistant/Intolerant Philadelphia Chromosome Positive Leukemias.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Interventions
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Intervention Details:
  • Drug: Ponatinib
    Patients will receive Ponatinib 45 mg by mouth as a single daily dose on an empty stomach (no food 2 hours prior to and after dosing) on day 1 and continuous once-daily dosing everyday thereafter. Each patient will receive daily Ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent.
    Other Name: AP24534
Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • Cytogenetic or PCR-based diagnosis of any phase of Ph+ acute lymphoblastic leukemia (ALL) and documented resistance or intolerance to imatinib and a second TKI (nilotinib, dasatinib, bosutinib)
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
  • Washout from prior anti-proliferative or anti-leukemia treatment: 3 days for hydroxyurea/anagrelide and tyrosine kinase inhibitors
  • < Grade 2 or baseline recovery from prior therapy related toxicities (except alopecia)
  • At least 3 months post allogeneic stem cell transplantation
  • Able to take oral capsules reliably
  • AST/ALT less than or equal to 2.5 times ULN, or less than 5 times ULN if attributable to involvement of leukemia
  • No active clinical or radiographic pancreatitis
  • At least 18 years of age
  • Willingness of male and female subjects to use reliable methods of birth control (when applicable)

Exclusion Criteria:

  • Subjects with Philadelphia Chromosome and BCR-ABL-negative chronic myeloid leukemia (CML)
  • Major surgery or radiotherapy within 7 days before the first dose of Ponatinib (recovery from any previous surgery should be complete before day 1)
  • Clinically significant active/uncompensated or uncontrolled cardiac disease (active congestive heart failure; uncontrolled angina or hypertension; myocardial infarction in the past 3 months; clinically significant untreated ventricular arrhythmia; diagnosed or suspected congenital or acquired prolonged QT syndrome; unexplained syncope; history of prolonged QTc)
  • Prolonged QTc (> 0.48 sec)
  • Pregnant or breastfeeding women
  • Evidence of serious active infection, or significant medical or psychiatric illness
  • Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, or clinically significant abnormal lab finding that would, in the investigator's judgment, make the subject inappropriate for this study
  • Prior resistance to Ponatinib
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01549548


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Ariad Pharmaceuticals
More Information
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Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01549548    
Other Study ID Numbers: IRB00008238
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by OHSU Knight Cancer Institute:
CML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Ponatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action