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We sought to determine the safety and toxicity of mocetinostat and its ability to reverse chemoresistance when administered with gemcitabine in patients with metastatic leiomyosarcoma resistant to prior gemcitabine-containing therapy. Participants with metastatic leiomyosarcoma received mocetinostat orally, 70\u2009mg per day, three days per week, increasing to 90\u2009mg after three weeks if well tolerated. Gemcitabine was administered at 1,000\u2009mg\/m<jats:sup>2<\/jats:sup> intravenously at 10\u2009mg\/m<jats:sup>2<\/jats:sup>\/minute on days five and 12 of every 21-day cycle. Disease response was evaluated with CT or MRI. Twenty participants with leiomyosarcoma were evaluated for toxicity. Median time to disease progression was 2.0 months (95% CI 1.54\u20133.12). Eighteen participants were evaluated for radiologic response by RECIST 1.1. Best responses included one PR and 12 SD. Tumor size reduced in 3 patients. Most common toxicities were fatigue, thrombocytopenia, anemia, nausea, and anorexia. One patient experienced a significant pericardial adverse event. No study-related deaths were observed. Rechallenging with gemcitabine by adding mocetinostat was feasible and demonstrated modest activity in patients with leiomyosarcoma. Further studies are needed to better define the role of HDAC inhibitors in patients with metastatic leiomyosarcoma.<\/jats:p>","DOI":"10.1155\/2018\/2068517","type":"journal-article","created":{"date-parts":[[2018,10,24]],"date-time":"2018-10-24T19:39:06Z","timestamp":1540409946000},"page":"1-9","source":"Crossref","is-referenced-by-count":20,"title":["SARC018_SPORE02: Phase II Study of Mocetinostat Administered with Gemcitabine for Patients with Metastatic Leiomyosarcoma with Progression or Relapse following Prior Treatment with Gemcitabine-Containing Therapy"],"prefix":"10.1155","volume":"2018","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9896-8084","authenticated-orcid":true,"given":"Edwin","family":"Choy","sequence":"first","affiliation":[{"name":"Massachusetts General Hospital, Division of Hematology Oncology, 55 Fruit Street, Boston, MA 02114, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karla","family":"Ballman","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine Healthcare Policy and Research, 402 East 67th Street, LA-225, New York, NY 10065, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Chen","sequence":"additional","affiliation":[{"name":"The Ohio State University Comprehensive Cancer Center, 1800 Cannon Drive, 250 Lincoln Tower, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A.","family":"Dickson","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 300 E. 66th Street, New York, NY 10065, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4633-6971","authenticated-orcid":true,"given":"Rashmi","family":"Chugh","sequence":"additional","affiliation":[{"name":"University of Michigan Comprehensive Cancer Center, 1500 E. 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