Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2013
Evaluation of food effect on pharmacokinetics of vismodegib in advanced solid tumor patients.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed.
- Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects.Antimicrobial agents and chemotherapy · 2021Trial
- A clinical drug-drug interaction study to evaluate the effect of a proton-pump inhibitor, a combined P-glycoprotein/cytochrome 450 enzyme (CYP)3A4 inhibitor, and a CYP2C9 inhibitor on the pharmacokinetics of vismodegib.Cancer chemotherapy and pharmacology · 2016Trial
- Ag-Sn@MOFs heterostructure enables ultrasensitive voltammetric determination of vismodegib in serum and urine.RSC advances · 2026Article
- Long-Term Management of Advanced Basal Cell Carcinoma: Current Challenges and Future Perspectives.Cancers · 2022Review
- Analysis of efficacy and safety of vismodegib therapy in patients with advanced basal cell carcinoma - real world multicenter cohort study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2022Article
- Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions.The AAPS journal · 2021Article
- Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing.Frontiers in research metrics and analytics · 2021Article
- A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation.The AAPS journal · 2020Article
- A Phase 1b Study of Vismodegib with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.Pulmonary therapy · 2019Article
- Hedgehog Pathway Inhibition for the Treatment of Basal Cell Carcinoma.Targeted oncology · 2019Review
- Review
- New developments in the treatment of basal cell carcinoma: update on current and emerging treatment options with a focus on vismodegib.OncoTargets and therapy · 2018Review
- Pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies and hepatic impairment.Cancer chemotherapy and pharmacology · 2017Article
- Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.OncoTargets and therapy · 2017Review
- Sonic hedgehog signaling in Basal cell nevus syndrome.Cancer research · 2014Review
- Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Article
- Determining the optimal dose in the development of anticancer agents.Nature reviews. Clinical oncology · 2014Review
- Successful Alternative Administration of Sonidegib in a Patient with Gorlin-Goltz Syndrome and Dysphagia: A Case Report.Case reports in dermatologyArticle
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
purposeVismodegib, an orally bioavailable small-molecule Smoothened inhibitor, is approved for treatment of advanced basal cell carcinoma (BCC). We conducted a pharmacokinetic study of vismodegib in patients with advanced solid tumors to explore the effects of food on drug exposure. EXPERIMENTAL
designIn part I, patients were randomized to fasting overnight (FO), a high fat meal (HF), or a low fat meal (LF) before a single dose of vismodegib 150 mg. Plasma concentrations of vismodegib were determined by a validated liquid chromatography-tandem mass spectrometry assay. Primary endpoints were C(max) and area under the curve (AUC(0-168)). In part II, patients randomized to FO or HF in part I took vismodegib 150 mg daily after fasting; those randomized to LF took it after a meal. Primary endpoints after two weeks were C(max) and AUC(0-24).
resultsSixty (22 FO, 20 HF, 18 LF) and 52 (25 fasting, 27 fed) patients were evaluable for primary endpoints in parts I and II, respectively. Mean C(max) and AUC(0-168) after a single dose were higher in HF than FO patients [ratios of geometric means (90% CI) = 1.75 (1.30, 2.34) and 1.74 (1.25, 2.42), respectively]. There were no significant differences in C(max) or AUC(0-24) between fasting and fed groups after daily dosing. The frequencies of drug-related toxicities were similar in both groups.
conclusionsA HF meal increases plasma exposure to a single dose of vismodegib, but there are no pharmacokinetic or safety differences between fasting and fed groups at steady-state. Vismodegib may be taken with or without food for daily dosing.
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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.