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The Future Glioblastoma Clinical Trials Landscape: Early Phase 0, Window of Opportunity, and Adaptive Phase I–III Studies
Purpose of ReviewInnovative clinical trial designs for glioblastoma (GBM) are needed to expedite drug discovery. Phase 0, window of opportunity, and...
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A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials
BackgroundThe past few decades have seen remarkable developments in dose-finding designs for phase I cancer clinical trials. While many of these...
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Antiangiogenic–immune-checkpoint inhibitor combinations: lessons from phase III clinical trials
Antiangiogenic agents, generally antibodies or tyrosine-kinase inhibitors that target the VEGF–VEGFR pathway, are currently among the few combination...
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A clinical phase I dose-finding design with adaptive shrinking boundaries for drug combination trials
BackgroundCombinations of drugs are becoming increasingly common in oncology treatment. In some cases, patients can benefit from the interaction...
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A dose-finding design for phase I clinical trials based on Bayesian stochastic approximation
BackgroundCurrent dose-finding designs for phase I clinical trials can correctly select the MTD in a range of 30–80% depending on various conditions...
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Evolving or immutable - phase I solid tumor trials in the era of precision oncology
In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted...
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P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants
BackgroundAfferent neuronal hypersensitization via P2X3 receptor signaling has been implicated as a driver of several disorders, including refractory...
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Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes
BackgroundThe aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of...
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Utility of Established Prognostic Scoring Systems for Patients with Advanced Pancreatic Adenocarcinoma Enrolled in Immunotherapy-Based Early-Phase Clinical Trials
BackgroundPancreatic ductal adenocarcinoma (PDAC) is a lethal malignancy for which multiagent chemotherapy is the mainstay of treatment resulting in...
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Safety and Pharmacokinetics of PSD502 in Healthy Chinese Male and Female Volunteers: Two Randomized, Double-Blind, Placebo-Controlled, Phase I Trials
Background and ObjectivePSD502 is a metered-dose spray for premature ejaculation. The two trials aimed to evaluate the safety and pharmacokinetics of...
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Psychological distress in patients with metastatic cancer enrolling on phase I clinical trials
PurposePsychological distress is common in patients with cancer and is associated with lower quality-of-life (QOL). Although distress among oncology...
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Core protocol development for phase 2/3 clinical trials in the leukodystrophy vanishing white matter: a consensus statement by the VWM consortium and patient advocates
BackgroundThe leukodystrophy “Vanishing White Matter” (VWM) is an orphan disease with neurological decline and high mortality. Currently, VWM has no...
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A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials
BackgroundGiven the inherent challenges of conducting randomized phase III trials in older cancer patients, single-arm phase II trials which assess...
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Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention
BackgroundPatients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical...
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Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials
Tapinarof cream 1% (VTAMA ® ; Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug...
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Analysis of phase III clinical trials in metastatic NSCLC to assess the correlation between QoL results and survival outcomes
BackgroundIn addition to improving survival outcomes, new oncology treatments should lead to amelioration of patients’ quality of life (QoL). Herein,...
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Establishing Optimal Control Cohorts for Phase 1 Trials: Retrospective Analysis of Clinical and Biological Outcomes in Neonates and Infants Undergoing Two-Ventricle Repair
Phase 1 trials are primarily conducted to evaluate the safety and feasibility of new interventions, usually without recruiting control patients. This...
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Seamless phase 2/3 design for trials with multiple co-primary endpoints using Bayesian predictive power
Seamless phase 2/3 design has become increasingly popular in clinical trials with a single endpoint. Trials that define success based on the...
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Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2)
IntroductionAtopic dermatitis (AD) is characterized by intense itch and other symptoms that negatively impact quality of life (QoL). This study...
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Adaptive designs were primarily used but inadequately reported in early phase drug trials
BackgroundFaced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive...
