Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized Phase 2 Study of AP26113 in Patients With ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

Trial Profile

A Randomized Phase 2 Study of AP26113 in Patients With ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Mar 2019

At a glance

  • Drugs Brigatinib (Primary)
  • Indications Carcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ALTA
  • Sponsors ARIAD Pharmaceuticals; Takeda Development Center Americas
  • Most Recent Events

    • 27 Nov 2018 According to a Takeda media release, the European Commission (EC) has granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib based on data from ALTA trial.
    • 21 Sep 2018 According to a Takeda media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Opinion was based on data from ALTA and ALTA-1L trials.
    • 01 Sep 2018 Outcomes of a population pharmacokinetic model developed to identify clinically relevant covariates that may impact posology and global drug development, using plasma concentration data of subjects who received brigatinib in five studies including this pivotal study,published in the Clinical Pharmacology in Drug Development: 2018 Annual Meeting of the American College of Clinical Pharmacology.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top