{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T04:24:37Z","timestamp":1768537477990,"version":"3.49.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T00:00:00Z","timestamp":1602633600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Solasia Pharma"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,2,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Two phase I studies of darinaparsin including Japanese and Korean patients with relapsed\/refractory peripheral T-cell lymphoma were performed to evaluate its safety (primary purpose), efficacy and pharmacokinetic profile (ClinicalTrials.gov: NCT01435863 and NCT01689220).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients received intravenous darinaparsin for 5 consecutive days at 200\u00a0mg\/m2\/day in 4-week\u00a0cycles, 300\u00a0mg\/m2\/day in 4-week\u00a0cycles or 300\u00a0mg\/m2\/day in 3-week\u00a0cycles.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Seventeen Japanese and 6 Korean patients were enrolled and treated. Drug-related adverse events developed in 18 patients (78%). Dose-limiting toxicity, grade 3 hepatic dysfunction, was reported on Day 15 of cycle 1 in 1 Japanese patient who received 300\u00a0mg\/m2\/day. The most common drug-related, grade\u00a0\u2265\u00a03 adverse events were lymphopenia (9%), neutropenia (9%) and thrombocytopenia (9%). No deaths occurred. In 14 evaluable patients, 1 and 3 patients had complete response and partial response, respectively. The plasma concentration-time profiles of arsenic, a surrogate marker for darinaparsin, were similar between Japanese and Korean patients. No significant difference was found in its pharmacokinetic profile.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>These data indicate the good tolerability and potential efficacy of darinaparsin in patients with relapsed\/refractory peripheral T-cell lymphoma. Darinaparsin 300\u00a0mg\/m2\/day for 5 consecutive days in 3-week\u00a0cycles is the recommended regimen for phase II study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyaa177","type":"journal-article","created":{"date-parts":[[2020,9,2]],"date-time":"2020-09-02T11:25:41Z","timestamp":1599045941000},"page":"218-227","source":"Crossref","is-referenced-by-count":15,"title":["Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea"],"prefix":"10.1093","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6853-4688","authenticated-orcid":false,"given":"Michinori","family":"Ogura","sequence":"first","affiliation":[{"name":"Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan"},{"name":"Hematology and Oncology, Kasugai Municipal Hospital, Kasugai, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Won-Seog","family":"Kim","sequence":"additional","affiliation":[{"name":"Hematology and Oncology, Samsung Medical Center, Seoul, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naokuni","family":"Uike","sequence":"additional","affiliation":[{"name":"Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan"},{"name":"Palliative Care, St. Mary's Hospital, Kurume, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Youko","family":"Suehiro","sequence":"additional","affiliation":[{"name":"Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan"},{"name":"Third Internal Medicine, Yamagata University Faculty of Medicine, Yamagata, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[{"name":"Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumiko","family":"Nagahama","sequence":"additional","affiliation":[{"name":"Product Development Division, Solasia Pharma K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Sonehara","sequence":"additional","affiliation":[{"name":"Product Development Division, Solasia Pharma K.K., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensei","family":"Tobinai","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,10,14]]},"reference":[{"key":"2021020810263119000_ref1","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1111\/j.1365-2141.2011.08651.x","article-title":"British Committee for Standards in Haematology. 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