NCT03840772

Eribulin in Advanced Solitary Fibrous Tumor

ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin

Detailed description

This is an Italian, non randomized, open label, multi center, investigator-initiated, Phase II, clinical study to explore the activity of eribulin in a population of patients with progressive, advanced (i.e. locally advanced or metastatic), molecularly proven SFT. Patients with a documented and centrally reviewed pathological diagnosis of locally advanced or metastatic SFT, and with an evidence of progression within the previous 6 months, may enter the study. Study treatments will be administered till progression or toxicity. The primary end-point of the study is overall response rate Secondary end-points are Progression Free Survival (PFS), Overall Survival (OS) clinical benefit rate, response rate as by Choi criteria, duration of response. Subjects already treated with one or two prior medical therapy regimens for the advanced phase, whatever agent used in first- or second-line, are eligible for inclusion in the study. Investigators will consider eligible for this study even patients naïve from chemotherapy, considering the limited activity of anthracycline in the disease.

Conditions

• Solitary Fibrous Tumor

Interventions

Type	Name	Description
DRUG	Eribulin	Treatment with eribulin

Timeline

• Start date: 2019-07-17
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2019-02-15
• Last updated: 2024-09-20

Locations

3 sites across 1 country: Italy