Clinical Trials

Moving our science forward.

Iclusig® (ponatinib), brigatinib (AP26113), and AP32788.

Ponatinib, brigatinib (AP26113), and AP32788 are currently in a number of ARIAD-sponsored clinical trials.

Ponatinib

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

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

The multi-center Phase 1/2 clinical trial in Japan of Iclusig 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. The Japanese study, which has completed enrollment, included 35 Japanese patients. Read Full Press Release

Brigatinib

Phase 3 ALTA 1L trial of brigatinib

In April 2015, ARIAD announced the initiation of a randomized, first-line Phase 3 clinical trial of brigatinib in adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor. The ALTA 1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial is designed to assess the efficacy of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of progression free survival (PFS).  Read Full Press Release

Phase 2 ALTA trial of brigatinib (AP26113)

In March 2014, ARIAD announced the initiation of its 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)

The international Phase 1/2 clinical trial of brigatinib (AP26113) is being conducted in patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). Patient enrollment in the trial is complete, with the last patient enrolled in July 2014. The primary endpoint in the Phase 2 portion of the trial is overall response rate. In April 2016, ARIAD announced updated clinical data from the trial. Read Full Press Release

Expanded Access Study of brigatinib

The purpose of this Expanded Access Program (EAP) is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

AP32788

Phase 1/2 study of oral EGFR/HER2 Inhibitor AP32788 in Non-Small Cell Lung Cancer

The purpose of this phase 1/2 study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of oral AP32788 in patients with non-small cell lung cancer (NSCLC). The trial will be conducted in two parts: a dose escalation phase, followed by an expansion phase. The goal of the dose escalation phase is to determine the safety profile of orally administered AP32788, including the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phased 2 dose (RP2D) and pharmacokinetic profile. Once the RP2D is established, the expansion phase will assess the preliminary anti-tumor activity of AP32788 in 4 histologically and molecularly defined NSCLC cohorts. Approximately 105 patients will be enrolled. Read Full Press Release