UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints
Sign Up to like & getrecommendations! Published in 2025 at "Statistics in Medicine"
DOI: 10.1002/sim.70098
Abstract: A primary objective of oncology dose‐finding trials for novel therapies is to determine an optimal biological dose (OBD) that is both tolerable and therapeutically beneficial for patients in subsequent clinical trials. These new therapeutic agents… read more here.
Keywords: unified transparent; efficacy; efficacy endpoints; toxicity efficacy ... See more keywords
TITE‐BOIN12: A Bayesian phase I/II trial design to find the optimal biological dose with late‐onset toxicity and efficacy
Sign Up to like & getrecommendations! Published in 2022 at "Statistics in Medicine"
DOI: 10.1002/sim.9337
Abstract: In the era of immunotherapies and targeted therapies, the focus of early phase clinical trials has shifted from finding the maximum tolerated dose to identifying the optimal biological dose (OBD), which maximizes the toxicity‐efficacy trade‐off.… read more here.
Keywords: efficacy; design; tite boin12; toxicity efficacy ... See more keywords
Real-world Data of Nivolumab for Patients With Advanced Renal Cell Carcinoma in the Netherlands: An Analysis of Toxicity, Efficacy, and Predictive Markers.
Sign Up to like & getrecommendations! Published in 2020 at "Clinical genitourinary cancer"
DOI: 10.1016/j.clgc.2020.10.003
Abstract: BACKGROUND Nivolumab, a programmed death 1 inhibitor, has been approved as second-line treatment for advanced renal cell carcinoma (RCC) in Europe since 2016. We investigated the toxicity and efficacy of nivolumab as well as potential… read more here.
Keywords: treatment; efficacy; toxicity; toxicity efficacy ... See more keywords
Checkerboard: a Bayesian efficacy and toxicity interval design for phase I/II dose-finding trials
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2020.1815033
Abstract: ABSTRACT The rise of targeted therapy and immunotherapy has challenged the conventional more-is-better phase I trial design paradigm that focuses on finding the MTD. In this article, we propose a novel model-assisted phase I/II design,… read more here.
Keywords: phase; efficacy; toxicity efficacy; checkerboard design ... See more keywords
TITE-STEIN: Time-to-event simple toxicity and efficacy interval design to accelerate phase I/II trials.
Sign Up to like & getrecommendations! Published in 2025 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2025.2592615
Abstract: Oncology dose-finding trials are shifting from identifying the maximum-tolerated dose (MTD) to determining the optimal biological dose (OBD), driven by the need for efficient methods that consider both toxicity and efficacy. This is particularly important… read more here.
Keywords: tite stein; efficacy; toxicity efficacy; design ... See more keywords
SMK/SM88 toxicity, efficacy, and patient reported outcomes in metastatic pancreas cancer.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2017.35.15_suppl.e14060
Abstract: e14060Background: SMK/SM-88 is a combination of novel tyrosine isomer (TI) and 3 low dose repurposed agents that are generally recognized as safe for typical use. Its mechanism of action is based o... read more here.
Keywords: efficacy patient; smk; toxicity efficacy; smk sm88 ... See more keywords
Toxicity and efficacy of lenvatinib plus pembrolizumab in advanced endometrial cancer: a real-world retrospective analysis
Sign Up to like & getrecommendations! Published in 2025 at "Frontiers in Oncology"
DOI: 10.3389/fonc.2025.1622253
Abstract: Background The treatment landscape for advanced recurrent endometrial cancer (EC) has been transformed with the introduction of lenvatinib and pembrolizumab, supported by results from the KEYNOTE-775 trial. However, the recommended 20 mg daily lenvatinib dose… read more here.
Keywords: real world; toxicity; endometrial cancer; efficacy ... See more keywords
Evaluation of Toxicity and Efficacy of Inotodiol as an Anti-Inflammatory Agent Using Animal Model
Sign Up to like & getrecommendations! Published in 2022 at "Molecules"
DOI: 10.3390/molecules27154704
Abstract: Chaga mushroom (Inonotus obliquus) comprises polyphenolic compounds, triterpenoids, polysaccharides, and sterols. Among the triterpenoid components, inotodiol has been broadly examined because of its various biological activities. The purpose of this study is to examine inotodiol… read more here.
Keywords: evaluation toxicity; efficacy inotodiol; toxicity; toxicity efficacy ... See more keywords