Eribulin in Advanced Solitary Fibrous Tumor (ERASING)

  • STATUS
    Recruiting
  • End date
    Apr 9, 2023
  • participants needed
    16
  • sponsor
    Italian Sarcoma Group
Updated on 14 February 2022

Summary

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

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 nave from chemotherapy, considering the limited activity of anthracycline in the disease.

Details
Condition Solitary Fibrous Tumor
Treatment Eribulin
Clinical Study IdentifierNCT03840772
SponsorItalian Sarcoma Group
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

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

Nave 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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