Trial reportInvestigational new drugs2013
Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study.
Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Incidence, Diagnosis, and Management of QT Prolongation Induced by Cancer Therapies: A Systematic Review.Journal of the American Heart Association · 2017Pooled it
- A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results.British journal of cancer · 2015Trial
- Searching for novel MDM2/MDMX dual inhibitors through a drug repurposing approach.Journal of enzyme inhibition and medicinal chemistry · 2024Article
- Dual activity of indolin-2-ones containing an arylidene motif: DNA and BSA interaction.RSC advances · 2023Article
- Nintedanib modulates type III collagen turnover in viable precision-cut lung slices from bleomycin-treated rats and patients with pulmonary fibrosis.Respiratory research · 2022Article
- Emerging Therapeutic Agents for Colorectal Cancer.Molecules (Basel, Switzerland) · 2021Review
- Review
- Review
- The Effect of Nintedanib on T-Cell Activation, Subsets and Functions.Drug design, development and therapy · 2021Article
- Rationale for the evaluation of nintedanib as a treatment for systemic sclerosis-associated interstitial lung disease.Journal of scleroderma and related disorders · 2019Review
- Clinical Pharmacokinetics and Pharmacodynamics of Nintedanib.Clinical pharmacokinetics · 2019Review
- Potential of nintedanib in treatment of progressive fibrosing interstitial lung diseases.The European respiratory journal · 2019Review
- QT Interval Prolongation Associated With Cytotoxic and Targeted Cancer Therapeutics.Current treatment options in oncology · 2019Review
- Deciphering role of FGFR signalling pathway in pancreatic cancer.Cell proliferation · 2019Review
- Pharmacokinetics of Nintedanib in Subjects With Hepatic Impairment.Journal of clinical pharmacology · 2018Article
- Population pharmacokinetics of nintedanib, an inhibitor of tyrosine kinases, in patients with non-small cell lung cancer or idiopathic pulmonary fibrosis.Cancer chemotherapy and pharmacology · 2018Article
- Phase I study of nintedanib in Japanese patients with advanced hepatocellular carcinoma and liver impairment.Cancer science · 2016Article
- Nintedanib in advanced NSCLC: management of adverse events.Lung cancer management · 2016Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSome targeted anticancer agents are associated with serious ventricular tachyarrhythmias, which may be predicted by electrocardiographic evaluation of drug-related QT prolongation. We studied the effects of nintedanib (BIBF 1120; an oral, triple angiokinase inhibitor targeting vascular endothelial growth factor, fibroblast growth factor, and platelet-derived growth factor receptors) on the QT interval in patients with renal cell carcinoma (RCC) participating in an open-label phase II trial.
methodsTreatment-naïve, adult patients with unresectable/metastatic, clear cell RCC received nintedanib 200 mg twice daily. QT intervals were evaluated at baseline (day -1), on day 1 (after the first dose), and on day 15 (steady state) by 12-lead electrocardiograms (ECGs) performed in triplicate. Pharmacokinetic sampling was also undertaken.
resultsAmong 64 evaluable patients, the upper limits of the 2-sided 90 % confidence intervals for the adjusted mean time-matched changes in QTcF interval (corrected for heart rate by Fridericia's method) from baseline to day 1 and 15 (primary ECG endpoint) were well below the regulatory threshold of 10 ms at all times. No relationship between nintedanib exposure and change from baseline in QTcF was seen. Nintedanib was generally well tolerated with no drug-related cardiovascular adverse events.
conclusionNintedanib administered at 200 mg twice daily was not associated with clinically relevant QT prolongation.
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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.