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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Treatment with eribulin
Azienda Ospedaliera Universitaria Paolo Giaccone
Palermo, PA, Italy
Policlinico Universitario Campus Biomedico
Roma, RM, Italy
Fondazione IRCCS INT Milano
Milan, Italy
RECIST 1.1 Overall response rate
Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1
Time frame: At week 6
Choi Response Rate
Proportion of patients with tumor size reduction ⩾10% or a decrease in tumour attenuation⩾15% measured with Choi criteria
Time frame: At week 6
Overall Survival (OS) at 3 years
Survival from the first eribulin dose to death for any cause
Time frame: At 3 years
Progression Free Survival (PFS) at 3 years
Survival without disease progression
Time frame: At 3 years
Clinical Benefit Rate
Proportion of patients with no disease progression after 18 weeks of therapy.
Time frame: At week 18
Safety of the treatment in term of adverse event
Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0
Time frame: Week 9, week 18, week 27, week 36
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