Therapy Detail

Therapy Name Capivasertib
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) 17 Capivasertib (AZD5363) decreases PI3K/AKT/mTOR signaling by inhibition of AKT1, AKT2, and AKT3, resulting in decreased cell proliferation (PMID: 22294718).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 granulosa cell tumor sensitive Capivasertib Phase I 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 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
AKT1 Q79K ovarian cancer sensitive Capivasertib Clinical Study Actionable In a clinical study, an ovarian cancer patient harboring AKT1 Q79K demonstrated tumor regression that lasted 14 months when treated with AZD5363 (PMID: 28489509). 28489509
AKT1 E17K Her2-receptor negative breast cancer predicted - 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
PTEN loss prostate cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, treatment with AZD5363 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
AKT1 E17K lung adenocarcinoma sensitive Capivasertib Clinical Study Actionable In a clinical study, a patient with lung adenocarcinoma harboring AKT1 E17K demonstrated a partial response when treated with AZD5363 (PMID: 28489509). 28489509
AKT1 E17K endometrial adenocarcinoma predicted - sensitive Capivasertib Phase II 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
AKT1 E17K cervical cancer sensitive Capivasertib Clinical Study Actionable In a clinical study, a patient with cervical cancer harboring AKT1 E17K demonstrated a partial response when treated with AZD5363 (PMID: 28489509). 28489509
AKT1 E17K parotid gland cancer predicted - sensitive Capivasertib Phase II 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 uterus leiomyosarcoma predicted - sensitive Capivasertib Phase II 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 E17K estrogen-receptor positive breast cancer predicted - sensitive Capivasertib Phase I Actionable In a Phase I trial, Capivasertib (AZD5363) treatment resulted in confirmed partial response in four and unconfirmed partial response in two patients with ESR1-positive breast cancer harboring AKT1 E17K (PMID: 28489509; NCT01226316). 28489509
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
AKT1 E17K meningothelial meningioma sensitive Capivasertib Clinical Study Actionable In a clinical case study, a patient with meningothelial meningioma harboring AKT1 E17K demonstrated stable disease and some tumor regression when treated with AZD5363 (PMID: 28376212). 28376212
PTEN loss TP53 loss prostate cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, treatment with AZD5363 improved overall survival and progression-free survival in mouse models of prostate cancer with inactivated PTEN and TP53 (PMID: 26910118). 26910118
PTEN loss renal carcinoma sensitive Capivasertib Preclinical - Pdx Actionable In a preclinical study, AZD5363 inhibited growth of renal cancer Pdx models with Pten loss (PMID: 22294718). 22294718
PTEN loss Advanced Solid Tumor sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, AZD5363 inhibited growth of various solid tumor cell culture models with loss of Pten (PMID: 22294718). 22294718
AKT1 E17K endometrial cancer sensitive Capivasertib Clinical Study Actionable In a clinical study, two patients with endometrial cancer harboring AKT1 E17K demonstrated a partial response when treated with AZD5363 (PMID: 28489509). 28489509
AKT1 E17K triple-receptor negative breast cancer sensitive Capivasertib Clinical Study Actionable In a clinical study, a patient with triple-receptor negative breast cancer harboring AKT1 E17K demonstrated a partial response when treated with AZD5363 (PMID: 28489509). 28489509
PTEN inact mut Advanced Solid Tumor sensitive Capivasertib Preclinical - Cell culture Actionable In a preclinical study, AZD5363 inhibited growth of various solid tumor cell culture models with inactivating Pten mutations (PMID: 22294718). 22294718
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 breast cancer sensitive Capivasertib Clinical Study Actionable In a clinical study, four patients with ESR1-positive breast cancer harboring AKT1 E17K demonstrated a partial response when treated with AZD5363 (PMID: 28489509). 28489509
AKT1 E17K breast cancer sensitive Capivasertib Preclinical Actionable In a preclinical study, 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
Clinical Trial Phase Therapies Title Recruitment Status
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 Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT02208375 Phase Ib/II Olaparib Capivasertib Vistusertib mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Cancer Active, not recruiting
NCT03310541 Phase I Capivasertib AZD5363 + Enzalutamide AZD5363 + Fulvestrant AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations Recruiting