Abstract | OBJECTIVE: METHODS: RESULTS: No dose-limiting toxicities were reported. The most common adverse events were diarrhea (n = 5), gastritis (n = 3), insomnia (n = 3) and pyrexia (n = 3). The most common ≥grade 3 adverse events were diarrhea (n = 2), increased transaminase levels (n = 2) and decreased appetite (n = 2). The maximum idelalisib plasma concentrations (Cmax) were achieved at 2.50 h (range: 1.50-4.00 h). The mean idelalisib plasma concentrations decreased over time but remained detectable in most patients at 12 h. All enrolled patients underwent efficacy evaluation by investigators, and five patients ( follicular lymphoma: n = 2, chronic lymphocytic leukemia: n = 3) achieved partial response. The median duration of partial response was 14.5 months (range: 3.7-31.3 months). CONCLUSION:
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Authors | Noriko Fukuhara, Tomohiro Kinoshita, Kazuhito Yamamoto, Hirokazu Nagai, Koji Izutsu, Go Yamamoto, Pankaj Bhargava, Nishan Rajakumaraswamy, Rita Humeniuk, Anita Mathias, Guan Xing, Masato Fukui, Kensei Tobinai |
Journal | Japanese journal of clinical oncology
(Jpn J Clin Oncol)
Vol. 50
Issue 12
Pg. 1395-1402
(Dec 16 2020)
ISSN: 1465-3621 [Electronic] England |
PMID | 32856068
(Publication Type: Clinical Trial, Phase I, Journal Article)
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Copyright | © The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected]. |
Chemical References |
- Antineoplastic Agents
- Purines
- Quinazolinones
- idelalisib
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Topics |
- Administration, Oral
- Aged
- Antineoplastic Agents
(administration & dosage, adverse effects, pharmacokinetics)
- Drug Administration Schedule
- Humans
- Japan
- Leukemia, Lymphocytic, Chronic, B-Cell
(drug therapy, pathology)
- Lymphoma, Follicular
(drug therapy, pathology)
- Male
- Middle Aged
- Purines
(administration & dosage, adverse effects, pharmacokinetics)
- Quinazolinones
(administration & dosage, adverse effects, pharmacokinetics)
- Recurrence
- Safety
- Treatment Outcome
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