{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T01:35:37Z","timestamp":1790213737365,"version":"4.1.0"},"reference-count":13,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T00:00:00Z","timestamp":1604102400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The recommended phase 2 dose (RP2D) of pamiparib, an investigational PARP1\/2 inhibitor, was established as 60\u00a0mg twice daily (BID) in a first\u2010in\u2010human (FIH) study (NCT02361723).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Chinese patients with advanced non\u2010mucinous high\u2010grade ovarian cancer (HGOC) or triple\u2010negative breast cancer (TNBC) whose disease either progressed despite standard therapy, or for which there is no standard therapy were enrolled in the dose\u2010escalation (DE) portion of a phase 1\/2 study (NCT03333915). The primary endpoint was safety\/tolerability; secondary objectives were pharmacokinetics and antitumor activity. <jats:italic>BRCA1<\/jats:italic>\/<jats:italic>2<\/jats:italic> mutation status was retrospectively evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Nine HGOC and six TNBC patients (N\u00a0=\u00a015; n\u00a0=\u00a04, 20\u00a0mg; n\u00a0=\u00a04, 40\u00a0mg; n\u00a0=\u00a07, 60\u00a0mg) were enrolled; as of 30 September 2019, one HGOC patient remained on treatment. Seven patients (n\u00a0=\u00a05, HGOC; n\u00a0=\u00a02, TNBC) had germline <jats:italic>BRCA1<\/jats:italic>\/<jats:italic>2<\/jats:italic> mutation (<jats:italic>gBRCA<\/jats:italic><jats:sup>mut<\/jats:sup>); all HGOC patients were resistant\/refractory to platinum. Asthenia and nausea (n\u00a0=\u00a012 each) were the most common treatment\u2010related adverse events (TRAEs). Decreased hemoglobin was the most common grade 3 TRAE (n\u00a0=\u00a03); no grade \u22654 AEs were observed. No dose\u2010limiting toxicities (DLTs) were reported. Pamiparib plasma exposure was similar to exposure observed in the FIH study after a single\u2010dose administration, albeit slightly higher at steady state. Among 13 RECIST\u2010evaluable patients, two with HGOC (<jats:italic>gBRCA<\/jats:italic><jats:sup>mut<\/jats:sup>, n\u00a0=\u00a01) achieved a confirmed partial response and six with HGOC (<jats:italic>gBRCA<\/jats:italic><jats:sup>mut<\/jats:sup>, n\u00a0=\u00a04) achieved stable disease; all TNBC RECIST\u2010evaluable patients (n\u00a0=\u00a05) reported progressive disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Pamiparib was generally well tolerated in Chinese patients, with durable responses observed in patients with HGOC. Based on these results, pamiparib 60\u00a0mg BID was confirmed as the RP2D.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.3575","type":"journal-article","created":{"date-parts":[[2020,10,31]],"date-time":"2020-10-31T08:25:34Z","timestamp":1604132734000},"page":"109-118","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Pamiparib dose escalation in Chinese patients with non\u2010mucinous high\u2010grade ovarian cancer or advanced triple\u2010negative breast cancer"],"prefix":"10.1002","volume":"10","author":[{"given":"Binghe","family":"Xu","sequence":"first","affiliation":[{"name":"National Cancer Center\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongmei","family":"Yin","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanjing Medical University Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mei","family":"Dong","sequence":"additional","affiliation":[{"name":"National Cancer Center\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Song","sequence":"additional","affiliation":[{"name":"National Cancer Center\/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Li","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanjing Medical University Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Huang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanjing Medical University Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tongshan","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanjing Medical University Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"He","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanjing Medical University Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiyan","family":"Mu","sequence":"additional","affiliation":[{"name":"BeiGene (Shanghai) Co., Ltd. Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Li","sequence":"additional","affiliation":[{"name":"BeiGene (Beijing) Co., Ltd. Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Song","family":"Mu","sequence":"additional","affiliation":[{"name":"BeiGene USA, Inc. San Mateo CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wa","family":"Zhang","sequence":"additional","affiliation":[{"name":"BeiGene (Beijing) Co., Ltd. Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miao","family":"Li","sequence":"additional","affiliation":[{"name":"BeiGene (Beijing) Co., Ltd. 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