ArticleBritish journal of clinical pharmacology2020
Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment.
Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed, 22 citations in OpenAlex.
- Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence.CPT: pharmacometrics & systems pharmacology · 2026Trial
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- Accounting for Differences in Plasma Protein Binding between Fish and Humans for Supporting Environmental Risk Assessment of Pharmaceuticals Using the Fish Plasma Model.Environmental science & technology · 2026Article
- A multicenter, prospective, non-interventional drug intensive monitoring study of olaparib in a large real-world Chinese patient cohort with ovarian cancer (DIM-OC).Journal of ovarian research · 2025Observational
- The poly (ADP-ribose) polymerase inhibitor olaparib attenuates established pulmonary fibrosis in a large animal model.BMC pulmonary medicine · 2025Article
- Cannabinoids and triple-negative breast cancer treatment.Frontiers in immunology · 2024Review
- Physiologically-based pharmacokinetic modeling for optimal dosage prediction of olaparib when co-administered with CYP3A4 modulators and in patients with hepatic/renal impairment.Scientific reports · 2023Article
- Exceptional responses to PARP inhibitors in patients with metastatic breast cancer in oncologic crisis.Breast cancer research and treatment · 2023Article
- Olaparib and advanced ovarian cancer: Summary of the past and looking into the future.Frontiers in pharmacology · 2023Review
- Pharmacokinetics and Pharmacodynamics of PARP Inhibitors in Oncology.Clinical pharmacokinetics · 2022Review
- Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations.Clinical pharmacology and therapeutics · 2022Review
- PARP Inhibitors for Breast Cancer: GermlineCancers · 2022Review
- Dose Adjustment of Poly (ADP‑Ribose) Polymerase Inhibitors in Patients with Hepatic or Renal Impairment.Drug design, development and therapy · 2022Review
- Pharmacokinetics and safety of rucaparib in patients with advanced solid tumors and hepatic impairment.Cancer chemotherapy and pharmacology · 2021Article
- Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment.British journal of clinical pharmacology · 2020Article
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Authors and funding
17 authors at 16 institutions in 6 countries.
Funding
Abstract
aimsOlaparib, a potent oral poly(ADP-ribose) polymerase inhibitor, is partially hepatically cleared. We investigated the pharmacokinetics (PK) and safety of olaparib in patients with mild or moderate hepatic impairment to provide dosing recommendations.
methodsThis Phase I open-label study assessed the PK, safety and tolerability of single doses of olaparib 300-mg tablets in patients with advanced solid tumours. Patients had normal hepatic function (NHF), or mild (MiHI; Child-Pugh class A) or moderate (MoHI; Child-Pugh class B) hepatic impairment. Blood was collected for PK assessments for 96 hours. Patients could continue taking olaparib 300 mg twice daily for long-term safety assessment.
resultsThirty-one patients received ≥1 dose of olaparib and 30 were included in the PK assessment. Patients with MiHI had an area under the curve geometric least-squares mean (GLSmean) ratio of 1.15 (90% confidence interval 0.72, 1.83) and a GLSmean maximum plasma concentration ratio of 1.13 (0.82, 1.56) vs those with NHF. In patients with MoHI, GLSmean ratio for area under the curve was 1.08 (0.66, 1.74) and for maximum plasma concentration was 0.87 (0.63, 1.22) vs those with NHF. For patients with mild or moderate hepatic impairment, no new safety signals were detected.
conclusionPatients with MiHI or MoHI had no clinically significant changes in exposure to olaparib compared with patients with NHF. The safety profile of olaparib did not differ from a clinically relevant extent between cohorts. No olaparib tablet or capsule dose reductions are required for patients with MiHI or MoHI.
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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 Socratic graph.