Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Eribulin will be administered at the dose of 1.23 mg/m², intravenously over 2-5 min on day 1 and day 8 of every 21 day cycle.

Study treatment will be administered until evidence of progression or unacceptable toxicity, patient's own willingness, non-compliance or according to clinical investigator's decision.

Eribulin

Silvia Stacchiotti, MD

Noemi Simone, MD

Giuseppe Badalamenti, MD

Badalamenti

Bruno Vincenzi, MD

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

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.

Eribulin in Advanced Solitary Fibrous Tumor

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

Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1

Proportion of patients with tumor size reduction ⩾10% or a decrease in tumour attenuation⩾15% measured with Choi criteria

Survival from the first eribulin dose to death for any cause

Proportion of patients with no disease progression after 18 weeks of therapy.

Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0

Spots Global Cancer Trial Database for rare sarcoma

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