ArticleBritish journal of clinical pharmacology2022
Concentration-QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations.
Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Efficacy and Safety of Capivasertib (AZD5363), a Potent, Oral Pan-AKT Inhibitor, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Concentration-QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval.CPT: pharmacometrics & systems pharmacology · 2025Trial
- The myeloperoxidase inhibitor mitiperstat (AZD4831) does not prolong the QT interval at expected therapeutic doses.Pharmacology research & perspectives · 2024Trial
- MicroRNAs and Alarmins in Cardio-Oncology: Biomarkers and Therapeutic Implications in Skin and Breast Cancer.International journal of molecular sciences · 2026Review
- Capivasertib as a Therapeutic Agent for Breast Cancer: Targeting AKT to Overcome Endocrine Resistance.Journal of clinical medicine · 2026Review
- Preclinical Rationale, Clinical Efficacy, and Safety of the Selective AKT Kinase Inhibitor Capivasertib in Metastatic Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Carcinoma: A Practical Narrative Review.Current oncology (Toronto, Ont.) · 2026Review
- A note on phase I interleaved versus parallel group ascending dose designs for concentration-QTc analyses.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Practical guide to concentration-QTc modeling: a hands-on tutorial.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Capivasertib/Fulvestrant in patients with HR+, HER2-low or HER2-negative locally advanced or metastatic breast cancer.Therapeutic advances in medical oncology · 2025Review
- "The emerging role of capivasertib in breast cancer".Breast (Edinburgh, Scotland) · 2022Review
- Concentration-QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations.British journal of clinical pharmacology · 2022Article
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Authors and funding
9 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Pharmacokinetics-matched digital electrocardiogram data (n = 503 measurements from 180 patients) collected in a first-in-human, multi-part, dose-escalation (from 80 to 800 mg) and dose expansion (at 480 mg) phase 1 study in patients with advanced solid malignancies, were used to assess potential risk of QT prolongation associated with the AKT inhibitor capivasertib. The relationship between plasma drug concentrations and baseline-adjusted Fridericia-corrected QT (ΔQTcF) values was estimated using a prespecified linear mixed-effects model. The model provided an unbiased reproduction of the experimental data set, estimating a small but positive correlation between capivasertib concentration and ΔQTcF. At the expected therapeutic dose (400 mg twice daily) the predicted mean ΔQTcF at the steady state maximum concentration was 3.97 ms with an upper limit of the 90% CI of 5.07 ms; below the 10 ms limit proposed by ICH E14 guidance. This analysis suggests that capivasertib is not expected to present a clinically significant risk for QT prolongation that is associated with pro-arrhythmic effects.
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