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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 6, 2012
Last Updated Date	March 13, 2013
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01549548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Compassionate Use Ponatinib
Official Title ^ICMJE	Treatment Plan for the Compassionate Use of Ponatinib (AP24534) in Patients With Imatinib-, Dasatinib-, and Nilotinib- Resistant/Intolerant Philadelphia Chromosome Positive Leukemias.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Expanded Access
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Philadelphia Chromosome Positive (Ph+) Leukemias Chronic Myeloid Leukemia
Intervention ^ICMJE	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
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	No longer available
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01549548
Other Study ID Numbers ^ICMJE	IRB00008238
Has Data Monitoring Committee	Not Provided
Responsible Party	OHSU Knight Cancer Institute
Study Sponsor ^ICMJE	OHSU Knight Cancer Institute
Collaborators ^ICMJE	Ariad Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	OHSU Knight Cancer Institute
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top