Phase I study of elisidepsin (E) in combination with carboplatin (C) in patients (pts) with advanced solid tumors.

• DOI: 10.1200/jco.2011.29.15_suppl.e13097
• Publication Date: 2017-02-23T18:58:03Z
• Authors: S. J. Faivre; S. Ropert; C. Coronado; J. Alcantara; B. De Miguel; A. Soto; S. A. Szyldergemajn; G. Loussilaho; O. Mir; F. Goldwasser; E. Raymond
• Keywords: Carboplatin

e13097 Background: E is a new synthetic depsipetide with broad in vitro/in vivo antitumor activity. induces cell death through profound alterations the plasmatic membrane of tumor cells, while C targets DNA cycle independent manner. In vitro experiments showed synergistic effect between and platinum compounds different lines. Objectives: To identify maximum tolerated dose (MTD) recommended (RD) given on day (d) 1 followed by as 3-hour i.v. infusion d1 d8, every three weeks, well safety feasibility, pharmacokinetic analysis Methods: Pts advanced solid tumors for whom no standard therapy available were recruited. A classical 3+3 successive cohort escalation design was followed. Results: The median age 15 pts included 59 (25-73) years, they had received 6 prior lines therapy, 10 males. Main types colorectal head neck (n=4, each). After 3 evaluable recruited at DL1 (1 mg + 4 AUC C) another DL2 (2 5 C), DLTs seen. Subsequently, DL3 (2.5 33% patients could not receive intended one DLT observed (AP increase > 14 d). Thus, reassumed DL2, which Of total (50%) did comply (grade thrombocytopenia days). Therefore, considered MTD. Toxicity generally mild, although reversible transaminase increases d8 led to frequent omissions preventing further escalation. Antitumor efficacy heavily pretreated pt STS who disease stabilization months. PK drug-drug interaction levels tested. Conclusions: No serious adverse events occurred but recurrent ALT AST delay treatment administrations. this schedule infra-optimal dose-intensity elisidepsin development.