Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

Summary

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.

Timeline

Start

2007-10

Primary completion

2010-10

Completion

2012-12

Outcome

Met primary endpoint

paper Ridaforolimus treatment led to a modest, although significant, improvement in PFS per independent review compared with placebo PMID 23715582 ↗

release “Top-line results for Phase III SUCCEED trial of ridaforolimus showed it met the primary endpoint in patients with metastatic soft-tissue or bone sarcomas.” merck.com ↗

Publications

• Results Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ridaforolimus	Small molecule	40 mg	Oral

Indications