Trial reportThe AAPS journal2016
Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis.
Trial report in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 101 citations in OpenAlex.
- Population Pharmacokinetic Models of Venetoclax in Hematologic Malignancies: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients.Investigational new drugs · 2024Trial
- Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.Advances in therapy · 2022Trial
- Semimechanistic Modeling to Guide Venetoclax Coadministration with Ritonavir and Digoxin.Clinical and translational science · 2020Trial
- Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.Clinical pharmacokinetics · 2019Trial
- Pharmacokinetics of the B-Cell Lymphoma 2 (Bcl-2) Inhibitor Venetoclax in Female Subjects with Systemic Lupus Erythematosus.Clinical pharmacokinetics · 2018Trial
- Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia.Clinical pharmacokinetics · 2017Trial
- Article
- Pharmacokinetics of venetoclax in a patient after whipple pancreaticoduodenectomy.Cancer chemotherapy and pharmacology · 2026Article
- Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting.Drug design, development and therapy · 2026Article
- Real-World Pharmacokinetic and Exposure-Response Characterization of Venetoclax in Chinese Patients with Hematological Malignancies.Drug design, development and therapy · 2026Article
- Optimizing Ibrutinib Posology in Chronic Lymphocytic Leukemia Using a Semi-Mechanistic Pharmacometric Framework.CPT: pharmacometrics & systems pharmacology · 2025Article
- Predicting the toxicity-efficacy ratio of venetoclax in real-world patients.Annals of hematology · 2025Article
- Phase Ib study of enzalutamide with venetoclax in patients with metastatic castration-resistant prostate cancer.Cancer chemotherapy and pharmacology · 2025Article
- Exposure toxicity of venetoclax in acute myeloid leukemia patients in the real-life setting: impact of high exposure on delayed neutropenia.Haematologica · 2025Article
- Semi-mechanistic population PK/PD model to aid clinical understanding of myelodysplastic syndromes following treatment with Venetoclax and Azacitidine.CPT: pharmacometrics & systems pharmacology · 2025Article
- Venetoclax concentration affects the incidence of haematological adverse events in patients with acute myeloid leukaemia.Frontiers in pharmacology · 2025Article
- Therapeutic Drug Monitoring: A New Hope for Individualised Treatment with Venetoclax.Current drug targets · 2025Review
- A Population Pharmacokinetics Study of Venetoclax Concomitant with Voriconazole in Patients with Hematologic Malignancies.Drug design, development and therapy · 2025Article
- Interindividual variability in CYP3A-mediated venetoclax metabolism in vitro and in vivo in patients with chronic lymphocytic leukemia.Clinical and translational science · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Venetoclax (ABT-199/GDC-0199) is a selective, potent, first-in-class BCL-2 inhibitor that restores apoptosis in cancer cells and has demonstrated clinical efficacy in a variety of hematological malignancies. The objective of this analysis was to characterize the population pharmacokinetics of venetoclax and identify demographic, pathophysiologic, and treatment factors that influence its pharmacokinetics. Plasma concentration samples from 505 subjects enrolled in 8 clinical studies were analyzed using non-linear mixed-effects modeling. Venetoclax plasma concentrations were best described by a two-compartment PK model with first-order absorption and elimination. The terminal half-life in cancer subjects was estimated to be approximately 26 h. Moderate and strong CYP3A inhibitors decreased venetoclax apparent clearance by 19% and 84%, respectively, while weak CYP3A inhibitors and inducers did not affect clearance. Additionally, concomitant rituximab administration was estimated to increase venetoclax apparent clearance by 21%. Gastric acid-reducing agent co-administration had no impact on the rate or extent of venetoclax absorption. Females had 32% lower central volume of distribution when compared to males. Food increased the bioavailability by 2.99- to 4.25-fold when compared to the fasting state. Mild and moderate renal and hepatic impairment, body weight, age, race, weak CYP3A inhibitors and inducers as well as OATP1B1 transporter phenotype and P-gp, BCRP, and OATP1B1/OATP1B3 modulators had no impact on venetoclax pharmacokinetics. Venetoclax showed minimal accumulation with accumulation ratio of 1.30-1.44. In conclusion, the concomitant administration of moderate and strong CYP3A inhibitors and rituximab as well as food were the main factors impacting venetoclax pharmacokinetics, while patient characteristics had only minimal impact.
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What OpenQuestion holds
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.