Eribulin in Advanced Solitary Fibrous Tumor (ERASING)

September 12, 2023 updated by: Italian Sarcoma Group

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS INT Milano
        • Contact:
        • Principal Investigator:
          • Silvia Stacchiotti, MD
    • PA
      • Palermo, PA, Italy, 90127
        • Recruiting
        • Azienda ospedaliera universitaria paolo giaccone
        • Contact:
        • Contact:
          • Badalamenti
        • Principal Investigator:
          • Giuseppe Badalamenti, MD
    • RM
      • Roma, RM, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Biomedico
        • Principal Investigator:
          • Bruno Vincenzi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Age ≥18 years
  3. Histological centrally and molecular confirmed diagnosis SFT
  4. Locally advanced disease and/or metastatic disease
  5. Measurable disease according RECIST 1.1
  6. Evidence of progression by RECIST 1.1 during the 6 months before study entry
  7. 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.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  9. Adequate bone marrow function
  10. Adequate organ function
  11. Cardiac ejection fraction ≥50%
  12. 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:

  1. Naïve patients
  2. More than 2 lines of anticancer treatment
  3. Previous treatment with any other anti-cancer investigational or not investigational agents within 21 days of first day of study drug dosing,
  4. 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
  5. Previous radiotherapy to 25% of the bone marrow
  6. Major surgery within 21 days prior to study entry
  7. 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
  8. Pregnancy or breast feeding
  9. 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
  10. 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
  11. 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
  12. Known history of human immunodeficiency virus infection
  13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
  14. 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
  15. 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
  16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  17. 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.
  18. Pre-existing peripheral neuropathy > CTCAE Grade 2.
  19. Expected non-compliance to medical regimens
  20. Subjects with known central nervous system metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 6
Overall Survival (OS) at 3 years
Time Frame: At 3 years
Survival from the first eribulin dose to death for any cause
At 3 years
Progression Free Survival (PFS) at 3 years
Time Frame: At 3 years
Survival without disease progression
At 3 years
Clinical Benefit Rate
Time Frame: At week 18
Proportion of patients with no disease progression after 18 weeks of therapy.
At week 18
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
Week 9, week 18, week 27, week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Collaborators

Eisai Inc.

Investigators

  • Principal Investigator: Silvia Stacchiotti, MD, Fondazione IRCCS INT di Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG-ERASING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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