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Background: We investigated the activity and safety of RE in doxorubicin-pretreated metastatic soft tissue sarcomas STS . Methods: REGOSARC NCT01900743 consisted of 4 independent cohorts of patients pts ho ere randomized 1:1 to receive either RE 160 mgd, 2128 d or PL, ith optional cross-over. Key-eligibility criteria ere age 18, metastatic sarcoma, x2264; 3 previous lines of treatment for metastatic sarcoma. The primary endpoint as progression-free survival PFS ith blinded central radiological revie. Statistical assumptions ere PFS = 1.6 months mo ith PL, PFS = 4.6 mo ith RE, 1-sided x3B1; = 0.1 and x3B2; = 0.05 0.2 in SYN cohort . Results: From July 2013 to December 2014, 181 pts previously exposed to doxorubicin 178, 98 percent , ifosfamide 107, 59 percent , trabectedin 70, 38 percent , and pazopanib 6, 3 percent ere enrolled 89 ith RE and 92 ith PL; including 70 cross-over . Activity endpoints are displayed in the Table belo. Four partial responses have been confirmed in RE arms, one in SYN pts and three in OTH pts 2 angiosarcomas and 1 solitary fibrous tumour . The drug-related maximal toxicity grade distribution by patient ith RE n=89 and PL n=92 as Grade 5 1 vs. 0; 1 percent vs. 0 percent; hepatitis , Grade 4 3 vs. 0; 3 percent vs. 0 percent , Grade 3 51 vs. 8; 57 vs. 9 percent , Grade 2 18 vs. 22; 20 vs. 24 percent and Grade 1 7 vs. 13; 8 vs. 14 percent . The most common AEs in RE-treated pts ere: asthenia 58, 63 percent , diarrhea 39, 44 percent , mucositis 39, 44 percent , Hand-Foot skin syndrome 39, 44 percent , anorexia 34, 38 percent and arterial hypertension 32, 36 percent . Conclusions: Excluding LIPO, RE is an active drug providing statistically and clinically significant PFS improvement in pre-treated STS pts. Safety of RE is as expected. Clinical trial information: lta href=http:clinicaltrials.govshoNCT01900743 NCT01900743ltcaption class=mtgabstract-table-title Survival outcomes in STS.CohortsArmnPFS mo HRpOS mo HRpLIPORE201.11.130.704.71.570.21LIPOPL231.78.8LMSRE283.70.450.00521.00.500.06LMSPL281.89.1SYNRE135.60.09lt 0.000113.40.870.79SYNPL141.06.7OTHRE292.90.450.00612.10.750.38OTHPL271.09.5Non-LIPORE704.00.36lt0.000113.40.670.06Non-LIPOPL691.09.0,J Clin Oncol 34, 2016 suppl; abstr 11003 ,NCT01900743,00:00.0,Sarcoma