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Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors
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Abstract
Purpose: To determine the maximum tolerated dose, dose-limiting toxicity (DLT), and recommended phase II dose of dasatinib in metastatic solid tumors refractory to standard therapies or for which no effective standard therapy exists. Experimental Design: In this phase I, open-label, dose-escalation study, patients received 35 to 160 mg of dasatinib twice daily in 28-day cycles either every 12 hours for 5 consecutive days followed by 2 nontreatment days every week (5D2) or as continuous, twice-daily (CDD) dosing. Results: Sixty-seven patients were treated (5D2, n = 33; CDD, n = 34). The maximum tolerated doses were 120 mg twice daily 5D2 and 70 mg twice daily CDD. DLTs with 160 mg 5D2 were recurrent grade 2 rash, grade 3 lethargy, and one patient with both grade 3 prolonged bleeding time and grade 3 hypocalcemia; DLTs with 120 mg twice daily CDD were grade 3 nausea, grade 3 fatigue, and one patient with both grade 3 rash and grade 2 proteinuria. The most frequent treatment-related toxicities across all doses were nausea, fatigue, lethargy, anorexia, proteinuria, and diarrhea, with infrequent hematologic toxicities. Pharmacokinetic data indicated rapid absorption, dose proportionality, and lack of drug accumulation. Although no objective tumor responses were seen, durable stable disease was observed in 16% of patients. Conclusion: Dasatinib was well tolerated in this population, with a safety profile similar to that observed previously in leukemia patients, although with much less hematologic toxicity. Limited, although encouraging, preliminary evidence of clinical activity was observed. Doses of 120 mg twice daily (5D2) or 70 mg twice daily (CDD) are recommended for further studies in patients with solid tumors. (Clin Cancer Res 2009;15(19):6232–40)
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“To date, Src inhibitors as monotherapy have not yielded promising results [46, 47].”
From Dasatinib, a Src inhibitor, sensitizes liver metastatic colorectal carcinoma to oxaliplatin in tumors with high levels of phospho-Src (2016) · cites this paper as [46]
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Metadata
- Authors
- Demetri, G. D., Lo Russo, P., MacPherson, I. R. J., Wang, D., Morgan, J. A., Brunton, V. G., Paliwal, P., Agrawal, S., Voi, M., & Evans, T. R. J.
- Affiliations
- Harvard University (US)
- Authors' Affiliations: 1Ludwig Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts; 2Karmanos Cancer Institute, Detroit, Michigan; 3Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; 4University of Edinburgh, Edinburgh, United Kingdom; and 5Bristol-Myers Squibb, Wallingford, Connecticut
- Corresponding author
- Demetri, George D.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2009-09-30
- Volume
- 15
- Issue
- 19
- Pages
- 6232-6240
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- OpenAlex
- W2143060756
- Cited by
- 150
- References
- 42
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 5 · 2023: 8 · 2022: 4 · 2021: 12 · 2020: 13 · 2019: 11 · 2018: 7 · 2017: 3 · 2016: 7 · 2015: 6 · 2014: 10 · 2013: 15 · 2012: 7
- FWCI
- 5.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- Funders
- Bristol-Myers Squibb
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Mechanisms and Therapy
- Keywords
- dasatinib, advanced solid tumors, metastatic solid tumors, maximum tolerated dose, dose-limiting toxicity, pharmacokinetics, dosing regimen, hematologic toxicity, proteinuria, tyrosine kinase inhibitors
- MeSH terms
- Dasatinib, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neoplasms, Pyrimidines, Thiazoles, Treatment Outcome, Drug Resistance, Neoplasm, Maximum Tolerated Dose
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