A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)
Completed
Ariad Pharmaceuticals
Phase 1/Phase 2
2011-09-20
The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to
determine the safety profile of orally administered brigatinib, including: the maximum
tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and
pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will
assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer
(NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or
mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.
A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
Completed
Ariad Pharmaceuticals
Phase 2
2014-06-04
The purpose of this study is to evaluate the efficacy and safety of two different dosing
regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or
metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with
crizotinib.
Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors
Recruiting
Academic Thoracic Oncology Medical Investigators Consortium
Phase 2
2017-03-09
The purpose of this study is to evaluate the safety and effectiveness of this investigational
drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small
cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got
worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act
on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
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