ArticleContemporary clinical trials communications2021
Design of phase 2 study of TAS-115, a novel oral multi-kinase inhibitor, in patients with idiopathic pulmonary fibrosis.
Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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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.
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Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- Pamufetinib (TAS-115) for chronic fibrosing interstitial lung diseases with a progressive phenotype: a double-blind, multicenter, phase 2b clinical trial.American journal of respiratory and critical care medicine · 2026Trial
- Drug-drug interactions with pioglitazone, losartan, and midazolam and anti-tumor efficacy and safety study of TAS-115 in patients with solid tumors.Cancer chemotherapy and pharmacology · 2026Article
- Upfront combination therapy with nintedanib and anti-inflammatory agents for progressive pulmonary fibrosis: a multicentre, single-arm phase 2 study (TOP-ILD).ERJ open research · 2026Article
- Spatially resolved metabolomics visualizes heterogeneous distribution of metabolites in lung tissue and the anti-pulmonary fibrosis effect ofJournal of pharmaceutical analysis · 2024Article
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Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTAS-115, a novel multi-kinase inhibitor, demonstrated antifibrotic effects
methodsThis is an open-label, intra-patient comparison, exploratory phase 2 study of TAS-115 to evaluate the efficacy and safety in idiopathic pulmonary fibrosis (IPF) patients when orally administered at 200 mg once daily on a 5-day on and 2-day off regimen for 13 weeks. This study consists of three cohorts: previously treated with pirfenidone (Cohort P, n = 20), with nintedanib (Cohort N, n = 20), and treatment naïve (Cohort U, n = 10). Male or female patients aged ≥40 to <80 years who were diagnosed with IPF in the preceding five years and having a percent predicted forced vital capacity (%FVC) decline of ≥5% within the previous 6 months were enrolled in this study. The primary endpoint is change in the slope of %FVC decline at Week 13 from baseline. Key secondary endpoints are safety, change in FVC from baseline, proportion of the %FVC responders and change in percent predicted diffusing capacity of the lung carbon monoxide from baseline, which are assessed at Weeks 6, 13 and 26.
resultsEnrollment of 45 patients was completed in July 2019. Results will be reported in 2021. DISCUSSION: This trial is intended to demonstrate the clinical efficacy of TAS-115 in IPF patients who have not responded to pirfenidone or nintedanib, as well as in those who are pirfenidone/nintedanib treatment naïve. The safety and tolerability in this population will be assessed.
trial registrationJapicCTI-183898.
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