Onapristone prostate phase 1-2

• Research type

  Research Study

• Full title

  A Phase 1-2 Study of Onapristone in Patients with Advanced Castration-resistant Prostate Cancer

• IRAS ID

  145740

• Contact name

  Gerhardt Attard

• Sponsor organisation

  Arno Therapeutics Inc

• Eudract number

  2013-004405-30

• ISRCTN Number

  xx

• Clinicaltrials.gov Identifier

  xx

• Research summary

  This is a two-stage safety and efficacy study with a randomized dose-finding stage intended to find a safe dose and an expansion stage designed to look at efficacy.

  This study will evaluate an extended-release formulation of onapristone in patients with prostate cancer in which the (progesterone receptor) PR may be driving tumor progression. A companion diagnostic to select patients whose prostate cancer expresses the activated form of the PR (APR) is under development and will be implemented in this study; it may be used to further enrich the selection of the population based upon ongoing review of the results. The 10mg starting dose was selected based on this dose being close to the lowest dose at which a pharmacological effect was observed in healthy volunteers. The extended-release formulation is intended to address the liver function test (LFT) elevations
  observed previously with an onapristone immediate-release formulation in patients with breast cancer.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/0088

• Date of REC Opinion

  12 Feb 2014

• REC opinion

  Further Information Favourable Opinion