ArticleCancer chemotherapy and pharmacology2018
A Phase 1, open-label, multicentre study to compare the capsule and tablet formulations of AZD5363 and explore the effect of food on the pharmacokinetic exposure, safety and tolerability of AZD5363 in patients with advanced solid malignancies: OAK.
Article in Cancer chemotherapy and pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- 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
- Article
- Dynamic changes of blood glucose level during capivasertib treatment in metastatic breast cancer: a case report.Diabetology international · 2025Article
- Population Pharmacokinetics and Exposure-Response Analyses for Capivasertib in Combination With Fulvestrant in Patients With Breast Cancer.Clinical and translational science · 2025Article
- An exposure-safety analysis to support the dosage of the novel AKT inhibitor capivasertib.Cancer chemotherapy and pharmacology · 2025Article
- Pharmacokinetic study of capivasertib and the CYP3A4 substrate midazolam in patients with advanced solid tumors.Cancer chemotherapy and pharmacology · 2024Article
- Population Pharmacokinetics of Capivasertib in Patients with Advanced or Metastatic Solid Tumours.Clinical pharmacokinetics · 2024Article
- PKMYT1 inhibits lung adenocarcinoma progression by abrogating AKT1 activity.Cellular oncology (Dordrecht, Netherlands) · 2023Article
- Targeting LRRC41 as a potential therapeutic approach for hepatocellular carcinoma.Frontiers in molecular biosciences · 2023Article
- "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
- A multidisciplinary approach to optimizing care of patients treated with alpelisib.Breast (Edinburgh, Scotland) · 2022Review
- Targeting Akt in Hepatocellular Carcinoma and Its Tumor Microenvironment.International journal of molecular sciences · 2021Review
- Characterization of AKT Somatic Mutations in Chinese Breast Cancer Patients.Cancer management and research · 2021Article
- Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients withClinical cancer research : an official journal of the American Association for Cancer Research · 2020Article
- Maximising the potential of AKT inhibitors as anti-cancer treatments.Pharmacology & therapeutics · 2017Review
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
purposeAZD5363 is a potent pan-AKT inhibitor originally formulated as a capsule; a tablet was developed for patient convenience and manufacturing ease. This study assessed the PK comparability of both formulations (Part A) and the effect of food (Part B) on the PK/safety of the tablet.
methodsAdults with advanced solid tumours received AZD5363 480 mg bid in a partially fasted state by tablet (Week 1) and capsule (Week 2) in a '4-days-on/3-days-off' schedule (Part A). PK parameters were evaluated using pre-defined 90% CIs for AUCτ and C
resultsIn evaluable patients (N = 11), the geometric least-squares mean ratios (tablet:capsule) for AUCτ and C
conclusionsPK and safety/tolerability of AZD5363 tablet and capsule were comparable. Food did not affect the bioavailability of AZD5363, but reduced the absorption rate without discernibly affecting safety/tolerability.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.