Clinical Trials

Moving our science forward.

Iclusig® (ponatinib) and brigatinib (AP26113).

Ponatinib and brigatinib (AP26113) are currently in a number of ARIAD-sponsored clinical trials.

OPTIC (Optimizing Ponatinib Treatment In CML) trial of ponatinib

Patient enrollment has started in the OPTIC (Optimizing Ponatinib Treatment In CML) trial of ponatinib. This randomized, dose-ranging trial is designed to evaluate three starting doses of ponatinib in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML) and is expected to inform the optimal use of Iclusig in these patients. Approximately 450 patients will be enrolled at clinical sites around the world. Read Full Press Release

OPTIC-2L

The randomized Phase 3 OPTIC-2L trial of ponatinib in second-line patients with CP-CML is designed to investigate the efficacy and safety of ponatinib, administered at two starting doses, compared with nilotinib, in patients who are resistant to front-line treatment with imatinib. The primary endpoint of the OPTIC-2L study, now open for patient enrollment, is major molecular response (MMR) by 12 months. Approximately 600 patients are expected to be enrolled at clinical sites in Europe, Asia, Latin America and Canada. Read Full Press Release

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

Phase 1/2 study of ponatinib in Japanese patients with CML and Ph+ ALL

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

Phase 2 ALTA trial of Brigatinib (AP26113)

In March 2014, ARIAD announced the initiation of its pivotal global Phase 2 ALTA (ALK in Lung Cancer Trial of brigatinib (AP26113) in patients with locally advanced or metastatic NSCLC who test positive for the ALK oncogene and were previously treated with crizotinib. This trial has reached full enrollment of approximately 220 patients and explores two different dose levels. Read Full Press Release

Phase 1/2 study of oral ALK inhibitor Brigatinib (AP26113)

In September of 2011, ARIAD announced the start of patient dosing in an international Phase 1/2 clinical trial of brigatinib (AP26113), an investigational inhibitor of anaplastic lymphoma kinase (ALK). Read Full Press Release