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Therapy Name Capivasertib
Synonyms
Therapy Description

Capivasertib (AZD5363) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, resulting in decreased cell proliferation (PMID: 22294718).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Capivasertib AZD5363 Akt Inhibitor (Pan) 19 Capivasertib (AZD5363) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, resulting in decreased cell proliferation (PMID: 22294718, PMID: 32532747, PMID: 32312891).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA amp lung squamous cell carcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Capivasertib (AZD5363) treatment resulted in no conformed response (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
AKT1 E17K parotid gland cancer predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase II (MATCH) trial, Capivasertib (AZD5363) treatment resulted in stable disease over 21 months in a patient with an oncocytic carcinoma of the parotid gland harboring AKT1 E17K mutation (PMID: 30429128; NCT02465060). 30429128
AKT1 E17K lung adenocarcinoma predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, a patient with lung adenocarcinoma harboring AKT1 E17K demonstrated a partial response when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
AKT1 E17K cervical cancer predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, a patient with cervical cancer harboring AKT1 E17K demonstrated a partial response when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
PIK3CA E545K gastrointestinal system cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, gastric cancer cells harboring PI3KCA E545K mutations were sensitive to the AKT inhibitor AZD5363 (PMID: 24088382). 24088382
AKT1 P68_C77dup breast cancer sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing AKT1 P68_C77dup demonstrated sensitivity by AZD5363 in culture, resulting in decreased cell survival (PMID: 29247016). 29247016
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 Capivasertib (AZD5363), demonstrating decreased cell proliferation in culture (PMID: 32070411). 32070411
AKT1 E17K uterus leiomyosarcoma predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase II (MATCH) trial, Capivasertib (AZD5363) treatment resulted in partial response in a patient with uterus leiomyosarcoma harboring AKT1 E17K mutation (PMID: 30429128; NCT02465060). 30429128
AKT1 Q79K ovarian cancer predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, an ovarian cancer patient harboring AKT1 Q79K demonstrated tumor regression that lasted 14 months when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
AKT1 E17K granulosa cell tumor sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, a patient with ovarian granulosa cell tumor cancer harboring subclonal AKT E17K demonstrated an overall tumor regression of 24% when treated with AZD5363, which lasted 253 days (PMID: 28489509). 28489509
AKT1 E17K endometrial cancer predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, two patients with endometrial cancer harboring AKT1 E17K demonstrated a partial response when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
AKT1 E17K Advanced Solid Tumor sensitive Capivasertib Phase II Actionable In a Phase II (MATCH) trial, Capivasertib (AZD5363) treatment resulted in partial response in 23% (8/35) and stable disease in 46% (16/35) of patients with advanced solid tumors harboring AKT1 E17K mutation (PMID: 30429128; NCT02465060). 30429128
AKT1 E17K Advanced Solid Tumor sensitive Capivasertib Phase I Actionable In a Phase I trial, Capivasertib (AZD5363) demonstrated safety and preliminary antitumor activity in patients with advanced solid tumors, resulted in stable disease in 27% (10/37) of patients and partial response in two patients, both of whom harbored an AKT1 E17K mutation (PMID: 26931343; NCT01353781). 26931343 detail...
AKT1 E17K endometrial adenocarcinoma predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase II (MATCH) trial, Capivasertib (AZD5363) treatment resulted in partial response in a patient with endometrioid adenocarcinoma harboring AKT1 E17K mutation (PMID: 30429128; NCT02465060). 30429128
PIK3CA E542K gastrointestinal system cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, gastric cancer cells harboring PI3KCA E542K mutations were sensitive to the AKT inhibitor AZD5363 (PMID: 24088382). 24088382
AKT1 E17K breast papillary carcinoma sensitive Capivasertib Phase I Actionable In a Phase I clinical trial, a patient with ER-positive, ERBB2 (HER2)-negative papillary breast carcinoma harboring AKT1 E17K had a sustained partial response to AZD5363 (PMID: 26351323). 26351323
PIK3CA mutant endometrioid ovary carcinoma sensitive Capivasertib Phase I Actionable In a Phase I clinical trial, AZD5363 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 E542K stomach cancer sensitive Capivasertib Case Reports/Case Series Actionable In a clinical case study, treatment with Capivasertib (AZD5363) 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 adenocarcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Capivasertib (AZD5363) treatment did not result in a conformed 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
AKT1 E17K AKT1 R465C Her2-receptor negative breast cancer sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, Capivasertib (AZD5363) treatment inhibited tumor growth in a patient-derived xenograft (PDX) model of Her2-negative breast cancer harboring AKT1 E17K and R465C (PMID: 32220884). 32220884
AKT1 E17K ovarian endometrial cancer sensitive Capivasertib Phase I Actionable In a Phase I clinical study, a patient with endometrioid ovarian carcinoma harboring AKT1 E17K had a sustained partial response to AZD5363 for more than two years (PMID: 26351323). 26351323
AKT1 E17K triple-receptor negative breast cancer predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, a patient with triple-receptor negative breast cancer harboring AKT1 E17K demonstrated a partial response when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
AKT1 E17K breast cancer sensitive Capivasertib Case Reports/Case Series Actionable In a Phase I trial, four patients with ESR1-positive breast cancer harboring AKT1 E17K demonstrated a partial response when treated with Capivasertib (AZD5363) (PMID: 28489509; NCT01226316). 28489509
AKT1 E17K breast cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, Capivasertib (AZD5363) inhibited growth and colony formation of breast cancer cells expressing AKT E17K in cell culture and in xenografts as well as breast cancer explant models harboring AKT E17K (PMID: 26351323). 26351323
AKT1 mutant lung adenocarcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Capivasertib (AZD5363) treatment did not result in a conformed 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
AKT1 mut PIK3CA mut Her2-receptor negative breast cancer sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, PIK3CA and AKT1 mutations are associated with increased sensitivity to Capivasertib (AZD5363) treatment in patient-derived xenograft (PDX) models of Her2-negative breast cancer compared to PDX models harboring AKT1, PIK3CA, and PTEN mutations (PMID: 32220884). 32220884
AKT1 E17K meningothelial meningioma predicted - sensitive Capivasertib Case Reports/Case Series Actionable In a clinical case study, a patient with meningothelial meningioma harboring AKT1 E17K demonstrated stable disease and some tumor regression when treated with Capivasertib (AZD5363) (PMID: 28376212). 28376212
PIK3CA mutant female reproductive organ cancer predicted - sensitive Capivasertib Phase I Actionable In a Phase I trial, treatment with AZD5363 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
AKT1 E17K Her2-receptor negative breast cancer sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, Capivasertib (AZD5363) treatment inhibited tumor growth in patient-derived xenograft (PDX) models of Her2-negative breast cancer harboring AKT1 E17K (PMID: 32220884). 32220884
AKT1 E17K Her2-receptor negative breast cancer sensitive Capivasertib Phase II Actionable In a Phase II (MATCH) trial, Capivasertib (AZD5363) treatment resulted in partial response in 23% (8/35) of patients with advanced solid tumors harboring AKT1 E17K mutation, 6 of the patients achieved partial response had hormone receptor-positive, Erbb2 (Her2)-negative breast cancer (PMID: 30429128; NCT02465060). 30429128
PIK3CA mutant breast cancer predicted - sensitive Capivasertib Preclinical Actionable In a preclinical study, AZD5363 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 AZD5363 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 H1047R stomach cancer sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, AZD5363 inhibited growth in a patient-derived xenograft model of gastric cancer harboring a PIK3CA H1047R mutation (PMID: 24088382). 24088382
AKT1 E17K estrogen-receptor positive breast cancer predicted - sensitive Capivasertib Phase I Actionable In a Phase I trial, Capivasertib (AZD5363) treatment in patients with ESR1-positive breast cancer harboring AKT1 E17K resulted in an objective response rate of 20% (4/20), with four patients achieving a partial response, stable disease at 24 weeks in 25% (5/20), a duration of response at 6 months or more in 10% (2/20), a clinical benefit rate of 45% at 24 weeks, and a median progression-free survival of 5.4 months (PMID: 32312891; NCT01226316). 32312891
PIK3CA mutant lung squamous cell carcinoma no benefit Capivasertib Case Reports/Case Series Actionable In a Phase II trial (NLMT), Capivasertib (AZD5363) treatment did not result in a conformed 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

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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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Clinical Trial Phase Therapies Title Recruitment Status
NCT03310541 Phase I Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations Active, not recruiting
NCT01226316 Phase I Capivasertib Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Active, not recruiting
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting


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