Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OHSU Knight Cancer Institute
With
Ariad Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
