Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients
Open accessAbstract
PURPOSE: To define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics (PK) of PEP02, a novel liposome-encapsulated irinotecan, in patients with advanced refractory solid tumors. METHODS: Patients were enrolled in cohorts of one to three to receive escalating dose of PEP02 in a phase I trial. PEP02, from 60 to 180 mg/m(2), was given as a 90-min intravenous infusion, every 3 weeks. RESULTS: A total of 11 patients were enrolled into three dose levels: 60 (one patient), 120 (six patients) and 180 mg/m(2) (four patients). DLT was observed in three patients, one at 120 mg/m(2) (grade 3 catheter-related infection) and two at 180 mg/m(2) (grade 4 neutropenia lasting for >3 days in one, grade 4 hematological toxicities and grade 4 diarrhea in the other). MTD was determined as 120 mg/m(2). Comparing with those after free-form irinotecan in the literature, the dose-normalized PK of SN-38 (the active metabolite) after PEP02 was characterized by lower C max, prolonged terminal half-life and higher AUC but with significant inter-individual variation. One patient who died of treatment-related toxicity had significantly higher C max and AUC levels of SN-38 than those of the other three patients at 180 mg/m(2). Post hoc pharmacogenetic study showed that the patient had a combined heterozygosity genotype of UGT1A1*6/*28. Two patients had objective tumor response. CONCLUSIONS: PEP02 apparently modified the PK parameters of irinotecan and SN-38 by liposome encapsulation. The MTD of PEP02 monotherapy at 3-week interval is 120 mg/m(2), which will be the recommended dose for future studies.
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Non-liposomal nanoparticle systems that have been approved for cancer treatment include Abraxane and NBTXR3 Hensify.
“Non-liposomal nanoparticle systems that have been approved for cancer treatment include Abraxane and NBTXR3 Hensify.348”
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- Authors
- Chang, T. C., Shiah, H. S., Yang, C. H., Yeh, K. H., Cheng, A. L., Shen, B. N., Wang, Y. W., Yeh, C. G., Chiang, N. J., Chang, J. Y., & Chen, L. T.
- Affiliations
- Chang Gung Memorial Hospital (TW)
- Taipei Medical University Hospital (TW)
- National Taiwan University Hospital (TW)
- PharmaEngine, Inc. (Taiwan) (TW)
- Kaohsiung Medical University (TW)
- National Health Research Institutes (TW)
- Corresponding author
- Chang, J. Y.
- Chen, L. T.
- Venue
- Cancer Chemotherapy and Pharmacology
- Published
- 2015-01-11
- Volume
- 75
- Issue
- 3
- Pages
- 579-586
- ISSN
- 0344-5704 (ISSN-L)
- 1432-0843
- PMC
- PMC4341010
- OpenAlex
- W2041354095
- Cited by
- 100
- References
- 21
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 7 · 2023: 6 · 2022: 9 · 2021: 9 · 2020: 13 · 2019: 7 · 2018: 5 · 2017: 15 · 2016: 15 · 2015: 3 · 2013: 1
- FWCI
- 5.50
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Cancer Chemotherapy and Pharmacology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Keywords
- irinotecan, nanoliposomal irinotecan, dose-limiting toxicity, maximum tolerated dose, advanced solid tumors, refractory cancer, UGT1A1 genotype, pharmacogenetics, liposome encapsulation, neutropenia, diarrhea, hematologic toxicity
- MeSH terms
- Irinotecan, UGT1A1 Enzyme, Adult, Antineoplastic Agents, Phytogenic, Camptothecin, Dose-Response Relationship, Drug, Female, Genotype, Half-Life, Humans, Infusions, Intravenous, Liposomes, Male, Middle Aged, Neoplasms, Pharmacogenetics, Glucuronosyltransferase, Treatment Outcome, Area Under Curve, Maximum Tolerated Dose, Nanoparticles
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