EZN-4176 in Castration-Resistant Prostate Cancer

• Research type

  Research Study

• Full title

  A Phase 1a/1b Open label Study Evaluating the Safety and Tolerability of EZN-4176, an Androgen Receptor mRNA Antagonist, in Adult Patients with Castration-Resistant Prostate Cancer

• IRAS ID

  63691

• Contact name

  Johann de Bono

• Sponsor organisation

  Enzon Pharmaceuticals, Inc

• Eudract number

  2010-021402-38

• ISRCTN Number

  Not Submitted

• Research summary

  This study is a first time in man trial of EZN-4176 in patients with an advanced form of prostate cancer called castrate resistant prostate cancer (CRPC).The purpose of the study is to assess different doses of the drug to find the maximum safe dose that can be given to patients and to understand the safety of the study drug; to understand what the body does to the drug; to understand what the study drug does to the body and to measure any anti-tumour activity by measuring any reduction in the patient's cancer. In the laboratory, EZN-4176 inhibits growth of androgen dependent and CRPC cells and may offer a therapeutic option for patients with resistant disease. Up to 50 patients aged 18 and over with CRPC will be enrolled in the study at one UK hospital site (Royal Marsden, Sutton). Patients will be given an infusion of EZN-4176 over 1 hour on days 1, 8, 15 and 22 of a 28 day cycle and will undergo regular examinations, blood tests and scans to assess the safety of the drug and the size of their tumour. Patients can be given repeated cycles of treatment while their cancer does not grow and while they are still receiving benefit.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/97

• Date of REC Opinion

  25 Jan 2011

• REC opinion

  Further Information Favourable Opinion