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    12h
    Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=92, Recruiting, Aminex Therapeutics, Inc.
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • fulvestrant • Truqap (capivasertib) • AMXT 1501
    19h
    DESTINY-Breast08: A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=138, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 expression • HER-2 underexpression • PGR positive
    |
    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    2d
    A Case of Grade 4 Hyperglycemia Induced by Capivasertib and Successfully Managed with Early Insulin Intervention. (PubMed, Surg Case Rep)
    Inpatient glucose monitoring enabled prompt detection of rapid glucose elevation and early intervention before the onset of DKA, resulting in a favorable outcome. Further clinical evidence is required to define optimal intervention strategies for grade 4 hyperglycemia associated with capivasertib therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • EGFR positive
    |
    fulvestrant • Truqap (capivasertib)
    3d
    CAPIcorn: Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment (clinicaltrials.gov)
    P3, N=250, Recruiting, West German Study Group
    New P3 trial • HEOR
    |
    Truqap (capivasertib)
    14d
    Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: expert opinion. (PubMed, NPJ Breast Cancer)
    Capivasertib, an AKT inhibitor, approved in combination with fulvestrant for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer with ≥1 PIK3CA, AKT1, and/or PTEN alterations, significantly improved progression-free survival in the CAPItello-291 phase 3 trial. However, capivasertib-associated adverse events of diarrhea, rash, and hyperglycemia may require proactive management. This article provides practical recommendations to support prevention and early intervention to optimize adherence and treatment outcomes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
    |
    fulvestrant • Truqap (capivasertib)
    22d
    FAKTION: Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer (clinicaltrials.gov)
    P1/2, N=149, Active, not recruiting, Velindre NHS Trust | Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Dec 2025
    Phase classification • Trial completion date
    |
    fulvestrant • Truqap (capivasertib)
    27d
    A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants (clinicaltrials.gov)
    P1, N=35, Not yet recruiting, AstraZeneca
    New P1 trial
    |
    Truqap (capivasertib)
    2ms
    Essential roles of mechanistic target of rapamycin in the induction of steroid resistance in group 2 innate lymphoid cells and severe asthma. (PubMed, J Pharmacol Exp Ther)
    The interleukin (IL)-33/thymic stromal lymphopoietin (TSLP)/IL-7-induced growth of group 2 innate lymphoid cells (ILC2) in vitro was resistant to dexamethasone (DEX), but suppressed by everolimus, an mTOR inhibitor, in a concentration-dependent manner...The combination of the pan-class I phosphatidylinositide-3 kinase inhibitor, buparlisib and the pan-Akt inhibitor, capivasertib also attenuated the resistance of IL-33/TSLP/IL-7-exposed ILC2s to DEX...This study demonstrates that activation of the phosphoinositide 3-kinase/protein kinase B/mechanistic target of rapamycin (mTOR) pathway induces steroid resistance in group 2 innate lymphoid cells. Targeting mTOR with everolimus restores steroid sensitivity, highlighting mTOR inhibition as a promising pharmacotherapy for steroid-resistant asthma.
    Journal
    |
    mTOR (Mechanistic target of rapamycin kinase) • IL7 (Interleukin 7) • TSLP (Thymic Stromal Lymphopoietin) • IL33 (Interleukin 33)
    |
    everolimus • Truqap (capivasertib) • buparlisib (AN2025) • sirolimus • dexamethasone
    2ms
    CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA (clinicaltrials.gov)
    P=N/A, N=130, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Truqap (capivasertib)
    2ms
    Disproportionality Analysis of Oral Toxicities Associated with PI3K/AKT/mTOR Pathway Inhibitors Using the FAERS Database. (PubMed, Pharmaceuticals (Basel))
    We performed a pharmacovigilance disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) to evaluate stomatitis reports for alpelisib, capivasertib, everolimus, and palbociclib... These results support the use of the SAMT as an efficient screening tool. Furthermore, these findings underscore the need for optimized stomatitis detection and continued monitoring, particularly for PI3K and mTOR inhibitors, in both clinical trials and postmarketing surveillance.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Truqap (capivasertib) • Itovebi (inavolisib)
    2ms
    Fibroblast Supernatants Modulate Treatment Responses in Human Papillomavirus Positive and Negative Oropharyngeal Cancer Cell Lines. (PubMed, Anticancer Res)
    Co-administering fibroblast BJ-hTERT cell supernatants with BYL719, JNJ-42756493, and PD-0332991 had an inhibitory effect on their effects on viability and confluence in some cell lines. This was never the case with cisplatin, and very rarely the case with docetaxel or AZD-5363.
    Preclinical • Journal
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    cisplatin • Ibrance (palbociclib) • docetaxel • Piqray (alpelisib) • Balversa (erdafitinib) • Truqap (capivasertib)
    2ms
    CAPItello-291: Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=818, Active, not recruiting, AstraZeneca | Trial completion date: Jun 2024 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    fulvestrant • Truqap (capivasertib)