drugset / Trial / NCT02121639
Open Label Phase I/Randomised,Double Blind Phase II Study in mCRPC of AZD5363 In Combination With DP Chemotherapy
Phase 1/2
Completed
160 enrolled
University Hospital Southampton NHS Foundation Trust
AstraZeneca · collabCancer Research UK · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The aim of the ProCAID study is to determine if the addition of the AKT inhibitor AZD5363 to docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in Metastatic castration resistant prostate cancer to a degree worthy of further investigation
Timeline
- Start
- 2014-01-29
- Primary completion
- 2020-10-08
- Completion
- 2021-09-13
Publications
- Crabb SJ, Griffiths G, Marwood E, Dunkley D, Downs N, Martin K, Light M, Northey J, Wilding S, Whitehead A, Shaw E, Birtle AJ, Bahl A, Elliott T, Westbury C, Sundar S, Robinson A, Jagdev S, Kumar S, Rooney C, Salinas-Souza C, Stephens C, Khoo V, Jones RJ. Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID). J Clin Oncol. 2021 Jan 20;39(3):190-201. doi: 10.1200/JCO.20.01576. Epub 2020 Dec 16.
- Crabb SJ, Birtle AJ, Martin K, Downs N, Ratcliffe I, Maishman T, Ellis M, Griffiths G, Thompson S, Ksiazek L, Khoo V, Jones RJ. ProCAID: a phase I clinical trial to combine the AKT inhibitor AZD5363 with docetaxel and prednisolone chemotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2017 Oct;35(5):599-607. doi: 10.1007/s10637-017-0433-4. Epub 2017 Feb 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capivasertib | Small molecule | 320 mg | Oral |
| Subject | Capivasertib | Small molecule | 400 mg | Oral |
| Subject | Capivasertib | Small molecule | 480 mg | Oral |