An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis

Trial Profile

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis

Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Dec 2017

At a glance

  • Drugs Bismuth salicylate (Primary) ; Budesonide (Primary) ; Colestipol (Primary) ; Loperamide (Primary) ; Mesalazine (Primary) ; Neratinib (Primary)
  • Indications Early breast cancer
  • Focus Adverse reactions; Registrational
  • Acronyms CONTROL
  • Sponsors Puma Biotechnology
  • Most Recent Events

    • 13 Dec 2017 According to a Puma Biotechnology media release,EMA has requested that the Scientific Advisory Group on Oncology provide an opinion on the clinical aspects of the MAA for neratinib at a meeting to be held on Jan 11, 2018. CHMP had issued its Day-180 List of Outstanding Issues,company expects to respond by the deadline of Dec 22, 2017.NDA submission was based on the data of Phase III ExteNET and Phase II CONTROL trial.
    • 06 Dec 2017 According to a Puma Biotechnology media release, updated interim results (n=321) will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).
    • 04 Dec 2017 Planned number of patients changed from 240 to 312.
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