Iclusig® (ponatinib) and AP26113.
Patient enrollment in all clinical studies of ponatinib is on temporary clinical hold. Iclusig (ponatinib) and AP26113 are currently in a number of ARIAD-sponsored clinical trials.
Iclusig (ponatinib) in GIST
In June of 2013, we announced the initiation of the Phase 2 trial of Iclusig (ponatinib) in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The trial is designed to provide initial clinical data evaluating the efficacy and safety of ponatinib in patients with GIST following failure of prior tyrosine kinase inhibitor (TKI) therapy. Read Full Press Release
In August 2012, we announced the initiation of a multi-center Phase 1/2 clinical trial in Japan of Iclusig. The trial is being conducted in Japanese patients with chronic myeloid leukemia (CML) who have failed treatment with dasatinib or nilotinib or with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who have failed prior tyrosine kinase inhibitors. Read Full Press Release
In September of 2011, ARIAD announced the start of patient dosing in an international Phase 1/2 clinical trial of AP26113, an investigational inhibitor of anaplastic lymphoma kinase (ALK). Read Full Press Release
In March 2014, ARIAD announced the initiation of its pivotal global Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) in patients with locally advanced or metastatic NSCLC who test positive for the ALK oncogene and were previously treated with crizotinib. This trial is expected to enroll 220 patients and will explore two different dose levels. Read Full Press Release