Use the checklist in our guide to gather the information you'll The investigational AKT inhibitor capivasertib (AZD5363) demonstrated clinical activity in patients with AKT-mutated cancers, suggesting the validity of tailoring treatment to tumor genes. The beneficial effect of capivasertib (AZD5363, AstraZeneca) appeared more pronounced among women with PIK3CA, AKT1 …
Epub 2017 Feb 1.Massard C, Chi KN, Castellano D, de Bono J, Gravis G, Dirix L, Machiels JP, Mita A, Mellado B, Turri S, Maier J, Csonka D, Chakravartty A, Fizazi K.Eur J Cancer. In this trial, they are looking at adding a drug called capivasertib.
A Phase I Dose-Escalation Study of Enzalutamide in Combination With the AKT Inhibitor AZD5363 (Capivasertib) in Patients With Metastatic Castration-Resistant Prostate Cancer - PubMed NCT02525068. Each bar represents an individual patient. Light colour indicates the patient previously received treatment with both abiraterone and enzalutamide; dark colour indicates prior treatment with only abiraterone and not enzalutamide. The study will be conducted on multiple centers (≤10) in USA and Spain. NA indicates not available. [Epub ahead of print] A phase I dose-escalation study of enzalutamide in combination with the AKT inhibitor AZD5363 (capivasertib) in patients with metastatic castration-resistant prostate cancer.
This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC).
Examine the clonality and genetic configuration of the AKT sensitizing mutation in the pretreatment specimens of study patients and their associated clinical response to AZD5363.II. Describe possible mechanisms of acquired resistance to AKT inhibition.COHORT I: Patients with prostate cancer previously treated with enzalutamide receive capivasertib (PO) twice daily (BID) with 4 days on and 3 days off and enzalutamide PO once daily (QD) on days 1-28. Clipboard, Search History, and several other advanced features are temporarily unavailable. need.
† indicates non-confirmed CTC conversions. Capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Phosphorylated extracellular signal-related kinases (pERK) refers to increased expression by IHC on post-treatment tumour biopsy samples relative to baseline indicated by +, whereas − indicates no increase. Prostate specific antigen or estrogen can cause the growth of tumor cells. This site needs JavaScript to work properly. Capivasertib with or without enzalutamide or … Patients indicated with a dot discontinued treatment before 12 weeks with no post-treatment PSA values obtained. 2020 Jun 25;21(12):4507. doi: 10.3390/ijms21124507. (Prostate Cohort)V. Determine the 12 week PSA response rate (RR). 2017 Oct;35(5):599-607. doi: 10.1007/s10637-017-0433-4.
The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.The two planned combination treatments during Part A of this study are:Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of data from Part A of this study.The study will include up to approximately 87 evaluable patients, divided among the 4 study parts as follows:Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9 patients per dose level).Part B1: Up to approximately 12 patients. To assess the clinical benefit rate (CBR) (complete response, partial response, or stable disease) at 24 weeks according to according to RECIST v1.1, PCWG3, or RANO as applicable, in patients with advanced solid tumors harboring mutations in AKT1, AKT2, or AKT3.II. The chemotherapy drug paclitaxel is a usual treatment for triple negative breast cancer that has come back or spread elsewhere in the body.