Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Astex Pharmaceuticals has begun Phase 1-2, open label, randomised AT13387-04 study in patients with castration-resistant prostate cancer (CRPC) who are no longer responding to treatment with standard of care therapies abiraterone acetate and steroids.
Subscribe to our email newsletter
The Phase 1 of the study will enrol up to 52 patients and monitor depletion of androgen receptors in tumour and Circulating Tumour Cells samples following treatment with AT13387 to establish safety of the combination, clinical activity, and confirm biological activity.
All the patients in Phase 1 will carry on with the same doses of abiraterone acetate and steroids received prior to entering the trial, and will be randomised to receive one of two different treatment regimens of AT13387 in combination with abiraterone acetate.
The best combination regimen in Part 1 will then move forward to Phase 2 where patients will be randomised to receive either the selected treatment regimen and dose of AT13387 in combination with abiraterone acetate or AT13387 alone. Part 2 is expected to enrol up to 112 patients.
Astex chairman and chief executive officer James Manuso said, "Despite developments in the treatment landscape, prostate cancer patients will continue to need new products, particularly ones that might be used in combination with other therapies, during the course of their disease."
The primary objective of the study is to evaluate the safety, tolerability and antitumor activity of AT13387 and abiraterone acetate in CRPC patients.
The secondary objectives include assessment of pharmacokinetics, pharmacodynamics, progression-free survival and overall survival of combination treatment of AT13387 and abiraterone acetate while identification of potential biomarkers for predicting antitumor activity includes other exploratory objectives.