ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)
Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin
• The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
• Age ≥18 years
• Histological centrally and molecular confirmed diagnosis SFT
• Locally advanced disease and/or metastatic disease
• Measurable disease according RECIST 1.1
• Evidence of progression by RECIST 1.1 during the 6 months before study entry
• Patients must be treated with at least one prior medical anticancer treatment line for the advanced phase of disease (both cytotoxic chemotherapy or target treatment allowed) and with a maximum of 2 lines.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Adequate bone marrow function
• Adequate organ function
• Cardiac ejection fraction ≥50%
• Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.