Compassionate Use Ponatinib

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01549548
First received: March 6, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 Intervention
Philadelphia Chromosome Positive (Ph+) Leukemias
Chronic Myeloid Leukemia
Drug: Ponatinib

Study Type: Expanded Access     What is 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 NLM:


Further study details as provided by OHSU Knight Cancer Institute:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549548

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Ariad Pharmaceuticals
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01549548     History of Changes
Other Study ID Numbers: IRB00008238
Study First Received: March 6, 2012
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
CML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014