MoST addendum 5 and substudy 10: Single arm, open label, signal seeking, phase IIa trial of the activity of eribulin in patients with advanced CD31 positive angiosarcoma and selected CD31 positive sarcomas. 

Trial Summary:

For patients with metastatic soft tissue sarcoma (STS) chemotherapy has led to a median survival of only 12 months across all histologies. Eribulin mesylate improves tumor blood perfusion through vascular remodeling. Normalization of vascular perfusion may be a therapeutic approach to inhibit motility, invasiveness, and aggressiveness of tumor cells.

We hypothesize that eribulin will lead to objective responses and/or durable disease control in patients with metastatic or unresectable CD31+ angiosarcoma and other selected CD31+ sarcomas including malignant and progressive epithelioid hemangioendothelioma.

The aim of substudy 10 is to assess the activity of eribulin in a population of patients with metastatic or unresectable angiosarcoma and other selected CD31 positive sarcomas.

To be eligible this trial, patients must continue to meet all of the inclusion criteria and none of the exclusion criteria specified in the MoST framework protocol (sections 5.3-5.8) and, in addition, meet all the inclusion criteria and none of the exclusion criteria below at the time of registration.

Supported By:

OHMR, CGMP, Eisai

Eligibility:

Subjects with metastatic or unresectable CD31+ angiosarcoma or other selected CD31+ sarcomas including malignant and progressive epithelioid hemangioendothelioma

Registration ID:

ACTRN12618000357257

Participation:

National

Status:

Closed

Activation Date:

5/02/2019

Chairs:

David Thomas

Contact:

most.study@sydney.edu.au