A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

Summary

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms The secondary objectives of the study are : * To compare the overall survival in the 2 treatment arms * To compare the objective response rate in the 2 treatment arms * To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy) * To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

Timeline

Start

2008-06

Primary completion

2013-04

Completion

2013-04

Outcome

Met primary endpoint

paper Progression-free survival was slightly, but significantly, improved in the ombrabulin group compared with the placebo group PMID 25864104 ↗

paper hazard ratio 0·76 [95% CI 0·59-0·98]; p=0·0302 PMID 25864104 ↗

Publications

• Blay JY, Papai Z, Tolcher AW, Italiano A, Cupissol D, Lopez-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saada-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ombrabulin	Other / unclassified	25 mg/m2	—

Indications