Eribulin in Advanced Solitary Fibrous Tumor (ERASING)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03840772|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solitary Fibrous Tumor||Drug: Eribulin||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Not controlled, single arm study|
|Masking:||None (Open Label)|
|Official Title:||ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
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.
Treatment with eribulin
Other Name: Intervention under investigation
- RECIST 1.1 Overall response rate [ Time Frame: At week 6 ]Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1
- Choi Response Rate [ Time Frame: At week 6 ]Proportion of patients with tumor size reduction ⩾10% or a decrease in tumour attenuation⩾15% measured with Choi criteria
- Overall Survival (OS) at 3 years [ Time Frame: At 3 years ]Survival from the first eribulin dose to death for any cause
- Progression Free Survival (PFS) at 3 years [ Time Frame: At 3 years ]Survival without disease progression
- Clinical Benefit Rate [ Time Frame: At week 18 ]Proportion of patients with no disease progression after 18 weeks of therapy.
- Safety of the treatment in term of adverse event [ Time Frame: Week 9, week 18, week 27, week 36 ]Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840772
|Contact: Silvia Stacchiotti, MD||0039022390 ext email@example.com|
|Contact: Noemi Simone, MD||0039022390 ext firstname.lastname@example.org|
|Azienda Ospedaliera Universitaria Paolo Giaccone||Not yet recruiting|
|Palermo, PA, Italy, 90127|
|Contact: Giuseppe Badalamenti, MD 0039091655 ext 4513 email@example.com|
|Principal Investigator: Giuseppe Badalamenti, MD|
|Policlinico Universitario Campus Biomedico|
|Roma, RM, Italy, 00128|
|Fondazione del Piemonte per l'Oncologia IRCC Candiolo|
|Candiolo, Torino, Italy, 10060|
|Fondazione IRCCS INT Milano|
|Milano, Italy, 20133|
|Principal Investigator:||Silvia Stacchiotti, MD||Fondazione IRCCS INT di Milano|