Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID).
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Disease Progression
Docetaxel
/ adverse effects
Double-Blind Method
Humans
Male
Middle Aged
Neoplasm Metastasis
Prednisolone
/ adverse effects
Progression-Free Survival
Prostatic Neoplasms, Castration-Resistant
/ drug therapy
Protein Kinase Inhibitors
/ adverse effects
Proto-Oncogene Proteins c-akt
/ antagonists & inhibitors
Pyrimidines
/ adverse effects
Pyrroles
/ adverse effects
Time Factors
United Kingdom
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333
Informations de publication
Date de publication:
20 01 2021
20 01 2021
Historique:
pubmed:
17
12
2020
medline:
17
8
2021
entrez:
16
12
2020
Statut:
ppublish
Résumé
Capivasertib is a pan-AKT inhibitor. Preclinical data indicate activity in metastatic castration-resistant prostate cancer (mCRPC) and synergism with docetaxel. ProCAID was a placebo controlled randomized phase II trial in mCRPC. Patients received up to ten 21-day cycles of docetaxel (75 mg/m One hundred and fifty patients were enrolled. Median cPFS was 7.03 (95% CI, 6.28 to 8.25) and 6.70 months (95% CI, 5.52 to 7.36) with capivasertib and placebo respectively (hazard ratio [HR], 0.92; 80% CI, 0.73 to 1.16; one-sided The addition of capivasertib to chemotherapy did not extend cPFS in mCRPC irrespective of PI3K/AKT/PTEN pathway activation status. The observed OS result (a secondary end point) will require prospective validation in future studies to address potential for bias.
Identifiants
pubmed: 33326257
doi: 10.1200/JCO.20.01576
pmc: PMC8078455
doi:
Substances chimiques
Protein Kinase Inhibitors
0
Pyrimidines
0
Pyrroles
0
Docetaxel
15H5577CQD
Prednisolone
9PHQ9Y1OLM
Proto-Oncogene Proteins c-akt
EC 2.7.11.1
capivasertib
WFR23M21IE
Banques de données
ClinicalTrials.gov
['NCT02121639']
ISRCTN
['ISRCTN69139368']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
190-201Subventions
Organisme : Cancer Research UK
ID : C9317/A16029
Pays : United Kingdom
Organisme : Cancer Research UK
ID : CRUK/12/042
Pays : United Kingdom
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