Capivasertib

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Information
Drug Name
Capivasertib
Description
Entry(CIViC)
12
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
stomach cancer PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		D Predictive Supports Sensitivity/Response Somatic 1 24088382 Detail
stomach cancer PIK3CA MUTATION PIK3CA MUTATION D Predictive Supports Sensitivity/Response Somatic 3 24088382 Detail
cancer PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		D Predictive Supports Sensitivity/Response Somatic 3 22294718 Detail
cancer PIK3CA MUTATION PIK3CA MUTATION D Predictive Supports Sensitivity/Response Somatic 3 22294718 Detail
Her2-receptor positive breast cancer PIK3CA MUTATION PIK3CA MUTATION D Predictive Supports Sensitivity/Response Somatic 2 22294718 Detail
Her2-receptor positive breast cancer PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) 		D Predictive Supports Sensitivity/Response Somatic 3 22294718 Detail
Her2-receptor positive breast cancer PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) 		D Predictive Supports Sensitivity/Response Somatic 3 22294718 Detail
cancer AKT1 p.Glu17Lys (p.E17K)
( ENST00000402615.6, ENST00000349310.7, ENST00000554848.5, ENST00000555528.5, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000555458.6, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) AKT1 p.Glu17Lys (p.E17K)
( ENST00000349310.7, ENST00000402615.6, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000554848.5, ENST00000555458.6, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) 		B Predictive Supports Sensitivity/Response Somatic 4 28489509 Detail
cancer PIK3CA MUTATION PIK3CA MUTATION B Predictive Supports Sensitivity/Response Somatic 4 28489509 Detail
breast cancer AKT1 p.Glu17Lys (p.E17K)
( ENST00000402615.6, ENST00000349310.7, ENST00000554848.5, ENST00000555528.5, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000555458.6, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) AKT1 p.Glu17Lys (p.E17K)
( ENST00000349310.7, ENST00000402615.6, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000554848.5, ENST00000555458.6, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) 		C Predictive Supports Sensitivity/Response Somatic 3 26351323 Detail
melanoma MTOR p.His1968Tyr (p.H1968Y)
( ENST00000361445.9, ENST00000703140.1 ) MTOR p.His1968Tyr (p.H1968Y)
( ENST00000361445.9, ENST00000703140.1 ) 		D Predictive Supports Sensitivity/Response Somatic 3 26490311 Detail
melanoma MTOR p.Pro2213Ser (p.P2213S)
( ENST00000361445.9, ENST00000703140.1 ) MTOR p.Pro2213Ser (p.P2213S)
( ENST00000361445.9, ENST00000703140.1 ) 		D Predictive Supports Sensitivity/Response Somatic 3 26490311 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
A patient derived mouse xenograft model was establ... PTEN PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		Sensitivity true CIViC Evidence detail
In a panel of 22 gastric cancer cell lines, 4 of 6... PIK3CA PIK3CA MUTATION PIK3CA MUTATION Sensitivity true CIViC Evidence detail
In a panel of 182 cell lines (162 with PIK3CA muta... PTEN PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		Sensitivity true CIViC Evidence detail
Sensitivity to pan-Akt inhibitor AZD5363 was asses... PIK3CA PIK3CA MUTATION PIK3CA MUTATION Sensitivity true CIViC Evidence detail
HER2 overexpressing breast cancer cell lines with ... PIK3CA PIK3CA MUTATION PIK3CA MUTATION Sensitivity true CIViC Evidence detail
Tumor xenografts in mice were established with the... PIK3CA PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) 		Sensitivity true CIViC Evidence detail
The HER2 breast cancer cell line KPL4 with PIK3CA ... PIK3CA PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R)
( ENST00000263967.4, ENST00000643187.1 ) 		Sensitivity true CIViC Evidence detail
AKT1 E17K mutations are oncogenic and occur in man... AKT1 AKT1 p.Glu17Lys (p.E17K)
( ENST00000402615.6, ENST00000349310.7, ENST00000554848.5, ENST00000555528.5, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000555458.6, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) AKT1 p.Glu17Lys (p.E17K)
( ENST00000349310.7, ENST00000402615.6, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000554848.5, ENST00000555458.6, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) 		Sensitivity true CIViC Evidence detail
In a study of 37 patients with AKT1 (E13K) mutatio... PIK3CA PIK3CA MUTATION PIK3CA MUTATION Sensitivity true CIViC Evidence detail
In a phase-I study of AZD5363, partial response wa... AKT1 AKT1 p.Glu17Lys (p.E17K)
( ENST00000402615.6, ENST00000349310.7, ENST00000554848.5, ENST00000555528.5, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000555458.6, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) AKT1 p.Glu17Lys (p.E17K)
( ENST00000349310.7, ENST00000402615.6, ENST00000407796.7, ENST00000553797.2, ENST00000554192.6, ENST00000554581.5, ENST00000554848.5, ENST00000555458.6, ENST00000555528.5, ENST00000649815.2, ENST00000683722.1, ENST00000714123.1, ENST00000714130.1 ) 		Sensitivity true CIViC Evidence detail
In a cell line (HEK293T) with expression of H1968Y... MTOR MTOR p.His1968Tyr (p.H1968Y)
( ENST00000361445.9, ENST00000703140.1 ) MTOR p.His1968Tyr (p.H1968Y)
( ENST00000361445.9, ENST00000703140.1 ) 		Sensitivity true CIViC Evidence detail
In a cell line (HEK293T) with expression of H1968Y... MTOR MTOR p.Pro2213Ser (p.P2213S)
( ENST00000361445.9, ENST00000703140.1 ) MTOR p.Pro2213Ser (p.P2213S)
( ENST00000361445.9, ENST00000703140.1 ) 		Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT02208375 Active, not recruiting Phase 1/Phase 2 mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian November 11, 2014 December 30, 2025
NCT02465060 Active, not recruiting Phase 2 Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) August 17, 2015 December 31, 2025
NCT03660826 Active, not recruiting Phase 2 Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone September 27, 2018 December 31, 2024
NCT03997123 Active, not recruiting Phase 3 Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC June 25, 2019 March 18, 2024
NCT04305496 Active, not recruiting Phase 3 Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer April 16, 2020 June 7, 2024
NCT04439123 Active, not recruiting Phase 2 Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) May 31, 2016 March 5, 2025
NCT04493853 Active, not recruiting Phase 3 Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency July 13, 2020 March 26, 2027
NCT04556773 Active, not recruiting Phase 1 A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer December 17, 2020 November 28, 2025
NCT05008055 Active, not recruiting Phase 2 Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma November 3, 2021 June 28, 2024
NCT04712396 Completed Phase 1 A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body February 1, 2021 March 25, 2021
NCT04944771 Completed Phase 1 Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants July 26, 2021 May 4, 2022
NCT04742036 Completed Phase 1 Capivasertib China PK Study February 22, 2021 July 29, 2022
NCT04087174 Completed Phase 1 A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer August 5, 2019 June 22, 2021
NCT04958226 Completed Phase 1 A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours October 15, 2021 February 15, 2023
NCT03742102 Recruiting Phase 1/Phase 2 A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer December 21, 2018 November 14, 2024
NCT03801369 Recruiting Phase 2 Olaparib in Combination With Either Durvalumab, Selumetinib, or Capivasertib or Ceralasertib Alone in Treating Patients With Metastatic Triple Negative Breast Cancer December 12, 2018 December 31, 2027
NCT05720260 Recruiting Phase 2 Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC January 17, 2023 January 31, 2027
NCT05348577 Recruiting Phase 3 Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) March 25, 2022 December 21, 2026
NCT05039801 Recruiting Phase 1 IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors September 9, 2021 May 29, 2026
NCT05563220 Recruiting Phase 1/Phase 2 Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer January 24, 2023 August 31, 2026
NCT05593497 Recruiting Phase 2 A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss May 31, 2024 August 1, 2027
NCT04862663 Recruiting Phase 3 Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) May 10, 2021 August 14, 2029
NCT02523014 Recruiting Phase 2 Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas August 2015 October 2024