Phase Ib/II study of elisidepsin in metastatic or advanced gastroesophageal cancer (IMAGE trial)

Russell Petty, Alan Anthoney, Jean-Philippe Metges, Maria Alsina, Anthony Gonçalves, Jennifer R. Brown, Clara Montagut, Katharina Gunzer, Gianluca Laus, Jorge Luis Iglesias Dios, Bernardo Miguel-Lillo, Patrick Bohan, Ramón Salazar (Lead / Corresponding author)

    Research output: Contribution to journalArticlepeer-review

    16 Citations (Scopus)


    Purpose: To determine the recommended dose and antitumor activity of single-agent elisidepsin as a 24-h intravenous (i.v.) infusion fortnightly [biweekly, d1 and 15 every 4 weeks (q4wk); Arm A, dose-intensity strategy] or as a 3-h i.v. infusion weekly (d1, 8, 15 and 22 q4wk; Arm B, dose-density strategy) in adult patients with unresectable, locally advanced or metastatic pretreated esophageal, gastroesophageal junction and gastric cancer.

    Methods: Patients were randomized to one of two elisidepsin dosing schedules. Phase Ib starting doses were 8.0 mg flat dose (FD) in Arm A and 3.0 mg FD in Arm B. Phase II subsequently explored antitumor activity of both dosing schedules at the respective recommended doses.

    Results: Forty-four patients received elisidepsin: 12 in stage Ib and 32 in stage II. The recommended doses were defined as 10 mg FD (Arm A) and 3.75 mg FD (Arm B). Both schedules were well tolerated. Most adverse events were mild or moderate, reversible and predictable with no meaningful differences between schedules. The pharmacokinetic profiles of both schedules were similar to those reported previously in patients with solid tumors treated with a comparable dose. An interim analysis found tumor control in one patient receiving elisidepsin fortnightly, and in none given elisidepsin weekly; patient accrual was therefore discontinued due to lack of efficacy.

    Conclusions: Both schedules at the recommended doses presented an acceptable safety profile, but lack of response means that we do not recommend further evaluation of single-agent elisidepsin as chemotherapy for unresectable, locally advanced or metastatic gastroesophageal cancer.

    Original languageEnglish
    Pages (from-to)819-27
    Number of pages9
    JournalCancer Chemotherapy and Pharmacology
    Issue number4
    Early online date10 Mar 2016
    Publication statusPublished - Apr 2016


    • Elisidepsin
    • PM02734
    • Esophageal cancer
    • Esophagogastric junction cancer
    • Gastric cancer
    • Gastroesophageal cancer


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