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

Who is this study for? Adult patients with Solitary Fibrous Tumor
What treatments are being studied? Eribulin
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Not yet recruiting
Candiolo
Fondazione IRCCS INT Milano
Recruiting
Milano
Azienda Ospedaliera Universitaria Paolo Giaccone
Not yet recruiting
Palermo
Policlinico Universitario Campus Biomedico
Recruiting
Roma
Contact Information
Primary
Silvia Stacchiotti, MD
silvia.stacchiotti@istitutotumori.mi.it
0039022390
Backup
Noemi Simone, MD
noemi.simone@istitutotumori.mi.it
0039022390
Time Frame
Start Date: July 17, 2019
Estimated Completion Date: April 2023
Participants
Target number of participants: 16
Treatments
Experimental: Eribulin
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.
Sponsors
Collaborators: Eisai Inc.
Leads: Italian Sarcoma Group

This content was sourced from clinicaltrials.gov

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