Phase 1b study to investigate the safety and tolerability of idelalisib in Japanese patients with relapsed/refractory follicular lymphoma and chronic lymphocytic leukemia.
Jpn J Clin Oncol
; 50(12): 1395-1402, 2020 Dec 16.
Article
em En
| MEDLINE
| ID: mdl-32856068
ABSTRACT
OBJECTIVE:
Idelalisib is an orally administered, highly selective inhibitor of phosphatidylinositol 3-kinase-δ. In this phase 1b study, the safety, tolerability and pharmacokinetics of idelalisib, an oral inhibitor of phosphatidylinositol 3-kinase-δ, were evaluated in Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.METHODS:
In total, six patients (follicular lymphoma n = 3, chronic lymphocytic leukemia n = 3) were enrolled to receive idelalisib 150 mg twice daily.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:
Idelalisib 150 mg twice daily was considered tolerable in Japanese patients with follicular lymphoma or chronic lymphocytic leukemia.(Clinical trial registration NCT02242045).Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Purinas
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Leucemia Linfocítica Crônica de Células B
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Linfoma Folicular
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Quinazolinonas
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Antineoplásicos
Limite:
Aged
/
Humans
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Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Jpn J Clin Oncol
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Japão