Trial reportCPT: pharmacometrics & systems pharmacology2017
A Pharmacometric Framework for Axitinib Exposure, Efficacy, and Safety in Metastatic Renal Cell Carcinoma Patients.
Trial report in CPT: pharmacometrics & systems pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00569946 (PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER), which is not on this map. Cited by 11 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.
Phase 2 study of ag-013736 as second-line treatment in patients with metastatic renal cell cancer
Who cites it
11 citing papers in PubMed.
- Exposure-Response Analysis of Necitumumab Efficacy in Squamous Non-Small Cell Lung Cancer Patients.CPT: pharmacometrics & systems pharmacology · 2017Trial
- Comparison of two-stage and joint TGI-OS modeling using data from six atezolizumab clinical studies in patients with metastatic non-small cell lung cancer.CPT: pharmacometrics & systems pharmacology · 2024Article
- Mechanistic characterization of oscillatory patterns in unperturbed tumor growth dynamics: The interplay between cancer cells and components of tumor microenvironment.PLoS computational biology · 2023Article
- A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Article
- Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine-kinase inhibitors.Clinical and translational science · 2023Article
- Multistate model for pharmacometric analyses of overall survival in HER2-negative breast cancer patients treated with docetaxel.CPT: pharmacometrics & systems pharmacology · 2021Article
- Tumor growth inhibition modeling of individual lesion dynamics and interorgan variability in HER2-negative breast cancer patients treated with docetaxel.CPT: pharmacometrics & systems pharmacology · 2021Article
- Progress and Opportunities to Advance Clinical Cancer Therapeutics Using Tumor Dynamic Models.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Review
- Model-Based Biomarker Selection for Dose Individualization of Tyrosine-Kinase Inhibitors.Frontiers in pharmacology · 2020Article
- A PK/PD Analysis of Circulating Biomarkers and Their Relationship to Tumor Response in Atezolizumab-Treated non-small Cell Lung Cancer Patients.Clinical pharmacology and therapeutics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The relationships between exposure, biomarkers (vascular endothelial growth factor (VEGF), soluble VEGF receptors (sVEGFR)-1, -2, -3, and soluble stem cell factor receptor (sKIT)), tumor sum of longest diameters (SLD), diastolic blood pressure (dBP), and overall survival (OS) were investigated in a modeling framework. The dataset included 64 metastatic renal cell carcinoma patients (mRCC) treated with oral axitinib. Biomarker timecourses were described by indirect response (IDR) models where axitinib inhibits sVEGFR-1, -2, and -3 production, and VEGF degradation. No effect was identified on sKIT. A tumor model using sVEGFR-3 dynamics as driver predicted SLD data well. An IDR model, with axitinib exposure stimulating the response, characterized dBP increase. In a time-to-event model the SLD timecourse predicted OS better than exposure, biomarker- or dBP-related metrics. This type of framework can be used to relate pharmacokinetics, efficacy, and safety to long-term clinical outcome in mRCC patients treated with VEGFR inhibitors. (ClinicalTrial.gov identifier NCT00569946.).
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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.