ReviewMolecular oncology2015
Early phase clinical trials to identify optimal dosing and safety.
Review in Molecular oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 55 papers, 2 of them syntheses 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.
Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells for Promoting Corneal Repair
Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Efficacy of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair
Who cites it
55 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Encapsulation and assessment of therapeutic cargo in engineered exosomes: a systematic review.Journal of nanobiotechnology · 2024Pooled it
- Pooled it
- Randomized Phase 1 Studies Evaluating the Safety, Tolerability, Pharmacokinetics, and Target Occupancy of Zampilimab in Healthy Participants.Clinical pharmacology in drug development · 2026Trial
- Development and evaluation of a large language model-based, retrieval-augmented generation application for query response in early oncology clinical trials.ESMO real world data and digital oncology · 2026Article
- Thymol as a natural monoterpenoid antibacterial agent: a comprehensive review of applications and current advances.Archives of microbiology · 2026Review
- Effects of the Synbiotic Formulation EDC-HHA01 on Glucose Regulation in Adults with Type 2 Diabetes and Prediabetes: A Randomized, Placebo-Controlled Study.Microorganisms · 2026Article
- A short review of dose-finding adaptive trial designs for clinical pharmacologists and non-statisticians in oncology.European journal of clinical pharmacology · 2026Review
- Prognostic value of existing scoring systems for early mortality in phase I immunotherapy trials: a head-to-head real-world cohort study.Frontiers in oncology · 2026Article
- Ferroptosis and Radiotherapy in Lung Cancer.Cells · 2025Review
- Observational
- Wearable nanopatch platforms for real-time miRNA sensing and editing: a vision for next-generation cancer management.Medical oncology (Northwood, London, England) · 2025Review
- Article
- Efficacy assessment in phase I clinical trials: endpoints and challenges.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Review
- siRNA-mediated inhibition of hTERT enhances the effects of curcumin in promoting cell death in precursor-B acute lymphoblastic leukemia cells: an in silico and in vitro study.Scientific reports · 2025Article
- Stronger together: a cross-SIG perspective on improving drug development.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Phase I/II Design for Selecting Subgroup-Specific Optimal Biological Doses for Prespecified Subgroups.Statistics in medicine · 2024Article
- Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.EClinicalMedicine · 2024Review
- Oncology Early-Phase Clinical Trials in the Middle East and North Africa: A Review of the Current Status, Challenges, Opportunities, and Future Directions.Journal of immunotherapy and precision oncology · 2024Review
- Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine.Heliyon · 2024Review
- Refining patient selection for next-generation immunotherapeutic early-phase clinical trials with a novel and externally validated prognostic nomogram.Frontiers in immunology · 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
4 authors.
Funding
Abstract
The purpose of early stage clinical trials is to determine the recommended dose and toxicity profile of an investigational agent or multi-drug combination. Molecularly targeted agents (MTAs) and immunotherapies have distinct toxicities from chemotherapies that are often not dose dependent and can lead to chronic and sometimes unpredictable side effects. Therefore utilizing a dose escalation method that has toxicity based endpoints may not be as appropriate for determination of recommended dose, and alternative parameters such as pharmacokinetic or pharmacodynamic outcomes are potentially appealing options. Approaches to enhance safety and optimize dosing include improved preclinical models and assessment, innovative model based design and dose escalation strategies, patient selection, the use of expansion cohorts and extended toxicity assessments. Tailoring the design of phase I trials by adopting new strategies to address the different properties of MTAs is required to enhance the development of these agents. This review will focus on the limitations to safety and dose determination that have occurred in the development of MTAs and immunotherapies. In addition, strategies are proposed to overcome these challenges to develop phase I trials that can more accurately define the recommended dose and identify adverse events.
Indexed as
Identifiers
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.