Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

Summary

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

Timeline

Start

2011-03-10

Primary completion

2015-01-02

Completion

2016-08-10

Outcome

Met primary endpoint

registry p =0.0169; Hazard Ratio (HR) 0.768 (95% CI 0.618 to 0.954) NCT01327885 ↗

paper Overall survival was significantly improved in patients assigned to eribulin compared with those assigned to dacarbazine PMID 26874885 ↗

release “Through the results of Study 309, eribulin has demonstrated overall survival benefit as a single agent chemotherapy in soft tissue sarcomas” eisai.com ↗

release “eribulin demonstrated a statistically significant extension in overall survival (OS) over the comparator treatment dacarbazine, and the study met its primary endpoint.” eisai.com ↗

release “Halaven demonstrated a statistically significant extension in the study's primary endpoint of overall survival (OS) over the comparator treatment dacarbazine” eisai.com ↗

Publications

• Schoffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dacarbazine	Small molecule	850 mg/m2	Intravenous
Comparator	Dacarbazine	Small molecule	1000 mg/m2	Intravenous
Comparator	Dacarbazine	Small molecule	1200 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.4 mg/m2	Intravenous

Indications