ACE: A PhaseI/II trial of AZD5069 in combination with enzalutamide
Research type
Research Study
Full title
ACE: Proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC)
IRAS ID
211557
Contact name
Johann de Bono
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2016-003141-28
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The purpose of this study is to find out the side effects and safety of a combination of the CXCR2 antagonist, AZD5069 in combination with the androgen receptor antagonist, enzalutamide in patients with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study groups of 3 to 6 patients will be treated with increasing doses of AZD5069 in combination with a fixed dose of enzalutamide(160mg once daily). Once Phase I has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Phase II part of the study. The Phase II part of the study will evaluate the optimized dose/schedule identified in Phase I of the study in patients with metastatic castration resistant prostate cancer.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0263
Date of REC Opinion
21 Mar 2017
REC opinion
Further Information Favourable Opinion