ArticleOncology and therapy2025
Phase I Study of Sorafenib Combined with Gemcitabine and Carboplatin in Patients with Advanced Solid Tumors.
Article in Oncology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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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Authors and funding
11 authors.
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Abstract
introductionA combination of targeted anticancer drugs with cytotoxic therapy can potentially overcome multidrug resistance. The multi-target kinase inhibitor sorafenib demonstrates synergistic activity when combined with chemotherapeutics in preclinical models. This phase I trial aimed to assess safety, tolerability, efficacy, and pharmacokinetics of sorafenib with gemcitabine and carboplatin.
methodsThis single-center, open-label, dose-escalation and dose-expansion study included patients with advanced solid tumors considered for palliative treatment with gemcitabine and carboplatin. The maximum tolerated dose (MTD) was determined using a classic 3 + 3 dose-escalation design. Antitumor activity was evaluated every two treatment cycles.
resultsIn total, 45 patients received treatment. Of the patients, 49% (n = 22) were male, and median age was 58 years [range: 27-72 years]. After dose-escalation, sorafenib 400 mg once daily (q.d.) on days 1-21, gemcitabine 500 mg/m
conclusionsA recommended phase 2 regimen of sorafenib 400 mg q.d. combined with gemcitabine 500 mg/m
trial registrationEudraCT: 2007-004129-75.
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