A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients
| Autor: | Melinda Lowe, Kelly Byrnes-Blake, H. Peter Soyer, James M. Olson, Dennis M. Miller, Lynda Spelman, Paul M. Griffin, Laura Ishak, Casey Rowe, Dominic Wood, Tarl W. Prow, Gordon Brandt, Miko Yamada, Julia Parrish-Novak |
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| Přispěvatelé: | Yamada, Miko, Miller, Dennis M, Lowe, Melinda, Rowe, Casey, Wood, Dominic, Soyer, H Peter, Byrnes-Blake, Kelly, Parrish-Novak, Julia, Ishak, Laura, Olson, James M, Brandt, Gordon, Griffin, Paul, Spelman, Lynda, Prow, Tarl W |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Medicine (General) NMSC non-melanoma skin cancer Nausea skin neoplasms cystine-knot miniproteins Gastroenterology Article Fluorescent dyes R5-920 Pharmacokinetics Surgical oncology Internal medicine Medicine Dosing Adverse effect Pharmacology fluorescent dyes CTX chlorotoxin business.industry NCI CTCAE National Cancer Institute's Common Terminology Criteria for Adverse Events PK pharmacokinetic(s) General Medicine medicine.disease Skin neoplasms Tolerability Pharmacodynamics medicine.symptom Skin cancer business Cystine-knot miniproteins |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 23, Iss, Pp 100830-(2021) |
| Popis: | BLZ-100 (tozuleristide) is an intraoperative fluorescent imaging agent that selectively detects malignant tissue and can be used in real time to guide tumor resection. The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of BLZ-100 and to explore the pharmacodynamics of fluorescence imaging of skin tumors. In this first-in-human study, BLZ-100 was administered intravenously to 21 adult patients 2 days before excising known or suspected skin cancers. Doses were 1, 3, 6, 12, and 18 mg, with 3–6 patients/cohort. Fluorescence imaging was conducted before and up to 48 h after dosing. BLZ-100 was well tolerated. There were no serious adverse events, deaths, or discontinuations due to adverse events, and no maximum tolerated dose (MTD) was identified. Headache (n = 2) and nausea (n = 2) were the only BLZ-100 treatment-related adverse events reported for >1 patient. Median time to maximal serum concentration was |
| Databáze: | OpenAIRE |
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