{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T23:55:47Z","timestamp":1767916547190,"version":"3.49.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2020,8,28]],"date-time":"2020-08-28T00:00:00Z","timestamp":1598572800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,12,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Idelalisib is an orally administered, highly selective inhibitor of phosphatidylinositol 3-kinase-\u03b4. In this phase 1b study, the safety, tolerability and pharmacokinetics of idelalisib, an oral inhibitor of phosphatidylinositol 3-kinase-\u03b4, were evaluated in Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In total, six patients (follicular lymphoma: n\u00a0=\u00a03, chronic lymphocytic leukemia: n\u00a0=\u00a03) were enrolled to receive idelalisib 150\u00a0mg twice daily.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>No dose-limiting toxicities were reported. The most common adverse events were diarrhea (n\u00a0=\u00a05), gastritis (n\u00a0=\u00a03), insomnia (n\u00a0=\u00a03) and pyrexia (n\u00a0=\u00a03). The most common \u2265grade 3 adverse events were diarrhea (n\u00a0=\u00a02), increased transaminase levels (n\u00a0=\u00a02) and decreased appetite (n\u00a0=\u00a02). The maximum idelalisib plasma concentrations (Cmax) were achieved at 2.50\u00a0h (range: 1.50\u20134.00\u00a0h). The mean idelalisib plasma concentrations decreased over time but remained detectable in most patients at 12\u00a0h. All enrolled patients underwent efficacy evaluation by investigators, and five patients (follicular lymphoma: n\u00a0=\u00a02, chronic lymphocytic leukemia: n\u00a0=\u00a03) achieved partial response. The median duration of partial response was 14.5\u00a0months (range: 3.7\u201331.3\u00a0months).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Idelalisib 150\u00a0mg twice daily was considered tolerable in Japanese patients with follicular lymphoma or chronic lymphocytic leukemia.<\/jats:p>\n                  <jats:p>(Clinical trial registration: NCT02242045)<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyaa153","type":"journal-article","created":{"date-parts":[[2020,7,31]],"date-time":"2020-07-31T11:28:35Z","timestamp":1596194915000},"page":"1395-1402","source":"Crossref","is-referenced-by-count":6,"title":["Phase 1b study to investigate the safety and tolerability of idelalisib in Japanese patients with relapsed\/refractory follicular lymphoma and chronic lymphocytic leukemia"],"prefix":"10.1093","volume":"50","author":[{"given":"Noriko","family":"Fukuhara","sequence":"first","affiliation":[{"name":"Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Kinoshita","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8588-8955","authenticated-orcid":false,"given":"Kazuhito","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Nagoya Medical Center, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-8057","authenticated-orcid":false,"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital, Tokyo, Japan"},{"name":"Department of Hematology, Toranomon Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Go","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Hematology, Toranomon Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pankaj","family":"Bhargava","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nishan","family":"Rajakumaraswamy","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA, 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