ArticleBritish journal of cancer2017
Phase I dose-escalation studies of roniciclib, a pan-cyclin-dependent kinase inhibitor, in advanced malignancies.
Article in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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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
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Multiethnic meta-analysis identifies ancestry-specific and cross-ancestry loci for pulmonary function.Nature communications · 2018Pooled it
- Hybrid dosing of the cyclin-dependent kinase (CDK) inhibitor flavopiridol in relapsed/refractory mantle cell lymphoma and diffuse large B-cell lymphoma.Leukemia & lymphoma · 2019Trial
- Novel Small Molecule Inhibitors of Cyclin-dependent Kinases as Anticancer Agents.Current medicinal chemistry · 2025Review
- Targeting CDK1 in cancer: mechanisms and implications.NPJ precision oncology · 2023Review
- Cyclin-dependent kinase (CDK) inhibitors in solid tumors: a review of clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022Review
- Review
- CDK inhibitors in cancer therapy, an overview of recent development.American journal of cancer research · 2021Review
- CDK1, CCNB1, and CCNB2 are Prognostic Biomarkers and Correlated with Immune Infiltration in Hepatocellular Carcinoma.Medical science monitor : international medical journal of experimental and clinical research · 2020Article
- Copanlisib synergizes with conventional and targeted agents including venetoclax in B- and T-cell lymphoma models.Blood advances · 2020Article
- Potent effects of roniciclib alone and with sorafenib against well-differentiated thyroid cancer.Endocrine-related cancer · 2018Article
- Pan-CDK inhibition augments cisplatin lethality in nasopharyngeal carcinoma cell lines and xenograft models.Signal transduction and targeted therapyArticle
Corrections and comments
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Authors and funding
19 authors at 13 institutions in 3 countries.
Funding
Abstract
backgroundTo evaluate safety, pharmacokinetics, and maximum tolerated dose of roniciclib in patients with advanced malignancies, with dose expansion to evaluate clinical benefit at the recommended phase II dose (RP2D).
methodsTwo phase I dose-escalation studies evaluated two roniciclib dosing schedules: 3 days on/4 days off or 4 weeks on/2 weeks off. The expansion phase included patients with small-cell lung cancer (SCLC), ovarian cancer, or tumour mutations involving the CDK signalling pathway.
resultsTen patients were evaluable in the 4 weeks on/2 weeks off schedule (terminated following limited tolerability) and 47 in the 3 days on/4 days off schedule dose-escalation cohorts. On the 3 days on/4 days off schedule, RP2D was 5 mg twice daily in solid tumours (n=40); undetermined in lymphoid malignancies (n=7). Common roniciclib-related adverse events included nausea (76.6%), fatigue (65.8%), diarrhoea (63.1%), and vomiting (57.7%). Roniciclib demonstrated rapid absorption and dose-proportional increase in exposure. One partial response (1.0%) was observed. In RP2D expansion cohorts, the disease control rate (DCR) was 40.9% for patients with ovarian cancer (n=25), 17.4% for patients with SCLC (n=33), and 33.3% for patients with CDK-related tumour mutations (n=6).
conclusionsRoniciclib demonstrated an acceptable safety profile and moderate DCR in 3 days on/4 days off schedule.
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Registered trials
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