Therapy Detail

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Therapy Name Capivasertib
Synonyms
Therapy Description

Truqap (capivasertib) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, potentially resulting in decreased cell proliferation (PMID: 22294718, PMID: 32532747, PMID: 32312891). Truqap (capivasertib) in combination with Faslodex (fulvestrant) is FDA-approved for use in patients with hormone receptor-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Capivasertib Truqap AZD5363|AZD 5363|AZD-5363 Akt Inhibitor (Pan) 21 Truqap (capivasertib) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, potentially resulting in decreased cell proliferation (PMID: 22294718, PMID: 32532747, PMID: 32312891). Truqap (capivasertib) in combination with Faslodex (fulvestrant) is FDA-approved for use in patients with hormone receptor-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant endometrioid ovary carcinoma sensitive Capivasertib Phase I Actionable In a Phase I clinical trial, Truqap (capivasertib) demonstrated safety and efficacy in patients with advanced solid tumors, including prolonged stable disease in one patient with a PIK3CA-mutant endometrioid ovarian cancer (American Association for Cancer Research; 06 Apr 2013-10 Apr 2013; Abstract LB-66). detail...
PIK3CA E545K gastrointestinal system cancer sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, gastric cancer cells harboring PIK3CA E545K demonstrated sensitivity to the AKT inhibitor Truqap (capivasertib), resulting in decreased proliferation in culture (PMID: 24088382). 24088382
PTEN inact mut Advanced Solid Tumor sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, Truqap (capivasertib) inhibited growth of various solid tumor cell culture models with inactivating Pten mutations (PMID: 22294718). 22294718
PTEN loss lung squamous cell carcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Truqap (capivasertib) treatment did not result in a confirmed response (0/4) or durable clinical benefit (0/2) in patients with squamous cell lung cancer harboring PTEN loss, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). 32669708
PIK3CA mutant lung adenocarcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Truqap (capivasertib) treatment did not result in a confirmed response (0/8) or durable clinical benefit (0/8) in patients with lung adenocarcinoma harboring mutations in PIK3CA, PTEN, or AKT, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). 32669708
PIK3CA H1047R stomach cancer sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, Truqap (capivasertib) inhibited growth in a patient-derived xenograft model of gastric cancer harboring a PIK3CA H1047R mutation (PMID: 24088382). 24088382
PIK3CA amp lung squamous cell carcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Truqap (capivasertib) treatment resulted in no confirmed responses (0/12) and durable clinical benefit in 9% (1/11) of patients with squamous cell lung cancer harboring PIK3CA amplification, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). 32669708
PTEN loss prostate cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, treatment with Truqap (capivasertib) decreased AKT phosphorylation and downstream signaling and reduced tumor burden in mouse models of PTEN-deficient prostate cancer, including both castration-naive and castration-resistant models (PMID: 26910118). 26910118
PIK3CA mutant breast cancer predicted - sensitive Capivasertib Preclinical Actionable In a preclinical study, Truqap (capivasertib) inhibited growth in breast cancer cell lines and xenograft models expressing PIK3CA mutations (PMID: 22294718). 22294718
PIK3CA mutant breast cancer predicted - sensitive Capivasertib Phase I Actionable In a Phase I trial, treatment with Truqap (capivasertib) was well-tolerated and resulted in tumor shrinkage in 46% (12/26) patients with PIK3CA-mutant breast cancer, with confirmed RECIST responses in 4% (1/28) of patients (PMID: 29066505; NCT01226316). 29066505
PIK3CA E545K stomach cancer sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, a gastric cancer cell line harboring PIK3CA E545K was sensitive to treatment with Truqap (capivasertib), demonstrating decreased cell proliferation in culture (PMID: 32070411). 32070411
PIK3CA E542K gastrointestinal system cancer sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, gastric cancer cells harboring PIK3CA E542K demonstrated sensitivity to the AKT inhibitor Truqap (capivasertib), resulting in decreased proliferation in culture (PMID: 24088382). 24088382
PIK3CA mutant female reproductive organ cancer predicted - sensitive Capivasertib Phase I Actionable In a Phase I trial, treatment with Truqap (capivasertib) was well-tolerated and resulted in tumor shrinkage in 56% (14/25) patients with PIK3CA-mutant gynecological cancers, however, the response rate was modest with confirmed RECIST responses in 8% (2/26) of patients (PMID: 29066505; NCT01226316). 29066505
PTEN loss TP53 loss prostate cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, treatment with Truqap (capivasertib) improved overall survival and progression-free survival in mouse models of prostate cancer with inactivated PTEN and TP53 (PMID: 26910118). 26910118
PTEN loss Advanced Solid Tumor sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, Truqap (capivasertib) inhibited growth of various solid tumor cell culture models with loss of Pten (PMID: 22294718). 22294718
PTEN loss renal carcinoma sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, Truqap (capivasertib) inhibited growth of renal cancer Pdx models with Pten loss (PMID: 22294718). 22294718
PIK3CA E542K stomach cancer sensitive Capivasertib Case Reports/Case Series Actionable In a clinical case study, treatment with Truqap (capivasertib) in a patient with gastric cancer harboring PIK3CA E542K resulted in a partial response, and in preclinical studies, led to decreased cell proliferation in a gastric cancer cell line harboring PIK3CA E542K (PMID: 32070411). 32070411
PIK3CA mutant lung squamous cell carcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Truqap (capivasertib) treatment did not result in a confirmed response (0/4) or durable clinical benefit (0/4) in patients with squamous cell lung cancer harboring PIK3CA mutations, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). 32669708
PTEN L108R breast cancer sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, Truqap (capivasertib) inhibited proliferation of a breast cancer cell line harboring PTEN L108R in culture (PMID: 30858154). 30858154
PTEN mutant lung adenocarcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Truqap (capivasertib) treatment did not result in a confirmed response (0/8) or durable clinical benefit (0/8) in patients with lung adenocarcinoma harboring mutations in PIK3CA, PTEN, or AKT, thus the cohort was closed due to futility (PMID: 32669708, NCT02664935). 32669708

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05008055 Phase II Capivasertib Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL) Active, not recruiting USA | GBR | FRA | ESP | CAN 2
NCT03310541 Phase I Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations Completed USA 0
NCT02523014 Phase II Abemaciclib GSK2256098 Vismodegib Capivasertib Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas Recruiting USA 0
NCT03182634 Phase II Fulvestrant Ceralasertib + Olaparib Capivasertib Fulvestrant + Neratinib The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial (plasmaMATCH) Unknown status GBR 0
NCT01226316 Phase I Capivasertib Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Active, not recruiting USA | ITA | GBR | FRA | ESP | CAN 4


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