We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access Program of Ponatinib

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592136
First Posted: May 7, 2012
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ariad Pharmaceuticals
May 3, 2012
May 7, 2012
March 13, 2013
 
Expanded Access Program of Ponatinib
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.
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.
Expanded Access
Drug: ponatinib
Patients will receive ponatinib 45 mg orally as a single dose once daily with or without food. Each patient will receive daily ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent
Other Name: AP24534
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592136
Ariad Pharmaceuticals
Ariad Pharmaceuticals
Not Provided
Not Provided
Ariad Pharmaceuticals
January 2013