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 | 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 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 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ARID1A del | stomach cancer | sensitive | Capivasertib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Truqap (capivasertib) inhibited proliferation and colony formation in an ARID1A knockout gastric cancer cell line in culture, and inhibited tumor growth in a cell line xenograft model (PMID: 39003371). | 39003371 |
| 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 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 |
| 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 |
| 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 |
| 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 | endometrioid ovary carcinoma | sensitive | Capivasertib | Case Reports/Case Series | Actionable | In a Phase I clinical trial, Truqap (capivasertib) demonstrated safety and efficacy in patients with advanced solid tumors, including prolonged stable disease (156 days) in one patient with a PIK3CA-mutant endometrioid ovarian cancer (Cancer Res 2013;73(8 Suppl):Abstract nr LB-66; NCT01226316, NCT01353781). | detail... |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| PIK3CA act mut STK11 del | estrogen-receptor positive breast cancer | resistant | Capivasertib | Preclinical - Cell culture | Actionable | In a preclinical study, PIK3CA-mutant, ESR1 (ER)-positive breast cancer cell lines with knockout of STK11 were resistant to treatment with Truqap (capivasertib) in culture (PMID: 33685991). | 33685991 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | Completed | USA | NLD | ITA | GBR | FRA | ESP | DNK | CAN | 2 |
| NCT06613516 | Phase II | Capivasertib | Effect of Capivasertib on ctDNA in ER Positive Breast Cancer (CaptAin) | Not yet recruiting | GBR | 0 |
| NCT05008055 | Phase II | Capivasertib | Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL) | Completed | USA | GBR | FRA | ESP | DNK | CAN | 1 |
| 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 |
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