CYPIDES

• Research type

  Research Study

• Full title

  Safety and pharmacokinetics of ODM-208 in patients with metastatic castration-resistant prostate cancer

• IRAS ID

  239796

• Contact name

  Danielle Richards

• Contact email

  danielle.richards@parexel.com

• Sponsor organisation

  Orion Corporation Orion Pharma

• Eudract number

  2017-002534-23

• Clinicaltrials.gov Identifier

  NCT03436485

• Duration of Study in the UK

  2 years, 5 months, 29 days

• Research summary

  Metastatic Castration-Resistant Prostate Cancer (mCRPC) is an incurable stage of prostate cancer in which the cancer keeps growing even when the amount of testosterone in the body is reduced to very low levels.

  There is currently no cure for mCRPC, however the following treatment options are available:

  • Hormonal targeting therapy (e.g. abiraterone, enzalutamide)
  • Hormonal ablation therapy - a type of minimally invasive procedure doctors use to destroy abnormal tissue that occurs with many conditions
  • Chemotherapy
  • Bone targeting agents
  • Radiotherapy
  • Brachytherapy - the treatment of cancer, especially prostate cancer, by the insertion of radioactive implants directly into the tissue

  The main purpose of this study is to find a safe and effective dose of ODM-208 study drug for the treatment of mCRPC. ODM-208 is study drug that is in the early phase of clinical research which means that it has not been approved for the treatment of prostate cancer and will be administered to humans for the first time in this study.

  All participants in this study will receive the study drug ODM-208 together with corticosteroids. It is anticipated that there will be many different dose levels of ODM-208 during the dose escalation part of the study. Each dose level will be given to separate groups of patients. The reason for allocating different dose levels of ODM-208 to different groups is to find the maximum dose of ODM-208 that has an acceptable safety profile. Participants can continue on study treatment as long as they benefit from the treatment.

  A maximum of 72 participants will take part in Part 1 across approximately 3 study centres.

  This study is being sponsored by Orion Corporation Orion Pharma.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  18/NW/0432

• Date of REC Opinion

  3 Sep 2018

• REC opinion

  Further Information Favourable Opinion