{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T10:23:52Z","timestamp":1790504632350,"version":"4.1.0"},"reference-count":34,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2012,1,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>Ridaforolimus is an inhibitor of mammalian target of rapamycin, an integral component of the phosphatidyl 3-kinase\/AKT signaling pathway, with early evidence of activity in sarcomas. This multicenter, open-label, single-arm, phase II trial was conducted to assess the antitumor activity of ridaforolimus in patients with distinct subtypes of advanced sarcomas.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>Patients with metastatic or unresectable soft tissue or bone sarcomas received ridaforolimus 12.5 mg administered as a 30-minute intravenous infusion once daily for 5 days every 2 weeks. The primary end point was clinical benefit response (CBR) rate (complete response or partial response [PR] or stable disease \u2265 16 weeks). Safety, progression-free survival (PFS), overall survival (OS), time to progression, and duration of response were also evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 212 patients were treated in four separate histologic cohorts. In this heavily pretreated population, 61 patients (28.8%) achieved CBR. Median PFS was 15.3 weeks; median OS was 40 weeks. Response Evaluation Criteria in Solid Tumors (RECIST) confirmed response rate was 1.9%, with four patients achieving confirmed PR (two with osteosarcoma, one with spindle cell sarcoma, and one with malignant fibrous histiocytoma). Archival tumor protein markers analyzed were not correlated with CBR. Related adverse events were generally mild or moderate and consisted primarily of stomatitis, mucosal inflammation, mouth ulceration, rash, and fatigue.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Single-agent ridaforolimus in patients with advanced and pretreated sarcomas led to PFS results that compare favorably with historical metrics. A phase III trial based on these data will further define ridaforolimus activity in sarcomas.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2011.35.6329","type":"journal-article","created":{"date-parts":[[2011,11,8]],"date-time":"2011-11-08T09:01:48Z","timestamp":1320742908000},"page":"78-84","source":"Crossref","is-referenced-by-count":217,"title":["Phase II Study of the Mammalian Target of Rapamycin Inhibitor Ridaforolimus in Patients With Advanced Bone and Soft Tissue Sarcomas"],"prefix":"10.1200","volume":"30","author":[{"given":"Sant P.","family":"Chawla","sequence":"first","affiliation":[{"name":"Sant P. Chawla, International Institute of Clinical Studies, Sarcoma Oncology Center, Santa Monica, CA; Arthur P. Staddon, Pennsylvania Oncology Hematology Associates, Philadelphia, PA; Laurence H. Baker and Scott M. Schuetze, University of Michigan School of Medicine, Ann Arbor, MI; Anthony W. Tolcher, South Texas Accelerated Research Therapeutics; Monica M. Mita and Kamalesh K. 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Chawla, International Institute of Clinical Studies, Sarcoma Oncology Center, Santa Monica, CA; Arthur P. Staddon, Pennsylvania Oncology Hematology Associates, Philadelphia, PA; Laurence H. Baker and Scott M. Schuetze, University of Michigan School of Medicine, Ann Arbor, MI; Anthony W. Tolcher, South Texas Accelerated Research Therapeutics; Monica M. Mita and Kamalesh K. Sankhala, Cancer Therapy Research Center, Institute for Drug Development, San Antonio, TX; Gina Z. D'Amato, H. Lee Moffitt..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott M.","family":"Schuetze","sequence":"additional","affiliation":[{"name":"Sant P. Chawla, International Institute of Clinical Studies, Sarcoma Oncology Center, Santa Monica, CA; Arthur P. Staddon, Pennsylvania Oncology Hematology Associates, Philadelphia, PA; Laurence H. Baker and Scott M. Schuetze, University of Michigan School of Medicine, Ann Arbor, MI; Anthony W. 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