An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

Trial Profile

An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

Completed
Phase of Trial: Phase II

Latest Information Update: 22 Nov 2017

At a glance

  • Drugs Vemurafenib (Primary) ; Cetuximab
  • Indications Cholangiocarcinoma; Colorectal cancer; Multiple myeloma; Non-small cell lung cancer; Ovarian cancer; Solid tumours
  • Focus Therapeutic Use
  • Acronyms VE-BASKET
  • Sponsors Roche
  • Most Recent Events

    • 06 Nov 2017 According to a Genentech media release, the U.S. Food and Drug Administration (FDA) has approved Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. The approval is based on data from this study.
    • 17 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 07 Aug 2017 According to a Genentech media release, the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review and Breakthrough Therapy Designation for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. The FDA is expected to make a decision on approval by December 7, 2017. The sNDA application included data from this study.
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