ERASING: Eribulin in Advanced Solitary Fibrous Tumor

Sponsor

Italian Sarcoma Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT03840772

Collaborator

Eisai Inc. (Industry)

Enrollment

Locations

Arm

44.5

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solitary Fibrous Tumor	Drug: Eribulin	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Not controlled, single arm studyNot controlled, single arm study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 17, 2019

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Eribulin Treatment with eribulin Other Names: Intervention under investigation

Arm

Intervention/Treatment

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.

Drug: Eribulin

Treatment with eribulin

Other Names:

Intervention under investigation

Outcome Measures

Primary Outcome Measures

RECIST 1.1 Overall response rate [At week 6]
Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1

Secondary Outcome Measures

Choi Response Rate [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 [At 3 years]
Survival from the first eribulin dose to death for any cause
Progression Free Survival (PFS) at 3 years [At 3 years]
Survival without disease progression
Clinical Benefit Rate [At week 18]
Proportion of patients with no disease progression after 18 weeks of therapy.
Safety of the treatment in term of adverse event [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Naïve patients
More than 2 lines of anticancer treatment
Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing,
Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
Previous radiotherapy to 25% of the bone marrow
Major surgery within 21 days prior to study entry
Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
Pregnancy or breast feeding
Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 . Medical history of a myocardial infarction < 6 months prior to initiation of study treatment. Unstable angina or myocardial infarction within 6 months of enrolment, Serious and potentially life-threatening arrhythmia
Subjects with a high probability of Long QT Syndrome or corrected QT interval prolongation of more than or equal to 501 msec , following correction of any electrolyte imbalance
Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
Known history of human immunodeficiency virus infection
Active or chronic hepatitis B or C requiring treatment with antiviral therapy
Medical history of hemorrhage or a bleeding event ≥ Grade 3 according Common Terminology Criteria for Adverse Events (CTCAE) within 4 weeks prior to the initiation of study treatment
Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to ≤ Grade 1 of CTCAE, except for peripheral neuropathy and alopecia.
Pre-existing peripheral neuropathy > CTCAE Grade 2.
Expected non-compliance to medical regimens
Subjects with known central nervous system metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera Universitaria Paolo Giaccone	Palermo	PA	Italy	90127
2	Policlinico Universitario Campus Biomedico	Roma	RM	Italy	00128
3	Fondazione del Piemonte per l'Oncologia IRCC Candiolo	Candiolo	Torino	Italy	10060
4	Fondazione IRCCS INT Milano	Milano		Italy	20133