AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT

Trial Profile

AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT

Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Nov 2017

At a glance

  • Drugs Alectinib (Primary) ; Erlotinib
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms Study 2
  • Sponsors Roche
  • Most Recent Events

    • 16 Nov 2017 Results of exploratory analysis evaluated cumulative incidence rates (CIRs) of CNS and non-CNS progression in alectinib-treated patients in the two pivotal phase II studies (NCT01801111 and NCT01871805), were published in the British Journal of Cancer.
    • 06 Nov 2017 According to a Genentech media release, the FDA has converted Alecensa's initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.
    • 05 Oct 2017 Status changed from active, no longer recruiting to completed.
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