CO39303: Ipatasertib+Abiraterone vs Placebo+Abiraterone in mCRPC

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TESTING IPATASERTIB PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE, RELATIVE TO PLACEBO PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE IN ADULT MALE PATIENTS WITH ASYMPTOMATIC OR MILDLY SYMPTOMATIC, PREVIOUSLY UNTREATED, METASTATIC CASTRATE-RESISTANT PROSTATE CANCER

• IRAS ID

  224973

• Contact name

  Johann De Bono

• Contact email

  johann.de-bono@icr.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2016-004429-17

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Clinicaltrials.gov Identifier

  111051, IND

• Duration of Study in the UK

  4 years, 0 months, 15 days

• Research summary

  Research Summary:
  Prostate cancer is the most commonly diagnosed cancer in men and despite recent advances in the treatment of prostate cancer, patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) experience significant morbidity and mortality related to their disease and the median life expectancy from time of first metastatic diagnosis remains less than 3 years.

  Ipatasertib is a small molecule that specifically targets and inhibits one of the pathways that is activated in prostrate cancer. Furthermore, preliminary tests have shown that the combination of Ipatasertib and hormonal therapy such as Abiraterone (Zytiga®) along with prednisone/prednisolone were even more effective at slowing tumour growth than when given alone.

  A total of 850 participants will take part in this study globally, designed to evaluate the efficacy, safety, and the body’s use of ipatasertib or placebo given with abiraterone.

  Participants with asymptomatic or mildly symptomatic mCRPC will be randomly assigned to daily treatment in 28-day cycles.

  Safety (including standard blood tests, ECG), tumour assessments and quality of life questionnaires will be carried out during the study. In addition to this, more specific tests will determine study drug levels, biomarkers and circulating genetic material in the blood.

  There will be approximately 32 participants recruited at 8 UK sites.

  The final lay summary of study results can be found here:
  https://forpatients.roche.com/en/trials/cancer/prostate-cancer/ipatasertib-plus-abiraterone-plus-prednisone-prednisolone--relat.html

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  17/LO/1068

• Date of REC Opinion

  30 Jun 2017

• REC opinion

  Favourable Opinion