GTx G200802 - GTx-024(Enobosarm) on ER+/AR+ Breast Cancer

• Research type

  Research Study

• Full title

  A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women

• IRAS ID

  171836

• Contact name

  Carlo Palmieri

• Contact email

  c.palmieri@liverpool.ac.uk

• Sponsor organisation

  GTx, Inc.

• Eudract number

  2015-001012-35

• Clinicaltrials.gov Identifier

  125281, IND Number:

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Breast cancer (BC) is the most common cause of cancer death among women, representing 522,000 deaths in 2012 and the most frequently diagnosed cancer among women in 140 of 184 countries worldwide.
  Overactive receptors on cells have been associated with BC growth. The oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) have been associated with BC growth however the androgen receptor (AR), has historically been considered anti-proliferative (the ability to inhibit cell growth) and beneficial.
  The Androgen Receptor (AR) is the most highly expressed receptor in BC with more than 75–95% of ER-positive and 10–35% of triple negative breast cancers (TNBC) expressing AR.
  This study will examine if a new drug called GTx-024 (Enobosarm) which binds to the androgen receptor can help patients with Metastatic or locally advanced estrogen receptor positive and androgen receptor positive (ER+/AR+) Breast Cancer (BC). The purpose of this study is to estimate the clinical benefit (via disease control) of Enobosarm given daily as an oral capsules (at the doses of 18mg or 9mg randomised at a 1:1 ratio) in patients with ER+/AR+ BC.
  The study is intended to be run in several countries in Europe (Bulgaria, Hungary, Czech Republic, Lithuania, Romania, UK, Ukraine) and USA and include 36-118 patients with a treatment period of 2 years

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0713

• Date of REC Opinion

  15 Oct 2015

• REC opinion

  Favourable Opinion