AZD5312 in patients with advanced cancer

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD5312 in Patients with Advanced Solid Tumours where the Androgen Receptor Pathway is a Potential Factor

• IRAS ID

  152969

• Contact name

  Hendrik-Tobias Arkenau

• Contact email

  Tobias.Arkenau@hcahealthcare.co.uk

• Sponsor organisation

  AstraZeneca

• Eudract number

  2014-000597-19

• Research summary

  This is a phase I study, in which adult patients with advanced forms of cancer will be given AZD312. The AR is a member of the steroid hormone receptor family pathway which plays a crucial role in the progression of some types of cancer. AZD5312 is designed to suppress the human AR expression, thereby providing potential therapeutic benefit for the treatment of metastatic castration resistant prostate cancer (mCRPC) and other AR-dependent cancers.

  The purpose of this study is to determine:

  • The safety and side effects of AZD5312
  • How the body handles the drug
  • What the drug does to the body and the cancer cells
  • A safe dose and schedule of AZD5312 for further testing.

  There are two parts of this study:

  Part A-Dose escalation: The study drug will be administered intravenously to groups of 3 to 6 subjects at a time with mCRPC, breast, bladder, ovarian, gastric and salivary duct cancer. If no bad side effects are seen, the next new group of subjects will receive a higher dose. This will continue until the recommended dose is found or until the side effects cannot be tolerated. Subjects may also be enrolled at lower doses to obtain more information about the experimental drug and to determine the recommended dose level for Part B of the study.
  
  Part B-Dose Expansion: Once the recommended dose of the study drug is found in Part A, up to 60 additional subjects with mCRPC and other types of cancer will enter Part B of the study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  14/LO/0605

• Date of REC Opinion

  11 Jul 2014

• REC opinion

  Further Information Favourable Opinion