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Eribulin in Advanced Solitary Fibrous Tumor (ERASING)

Primary Purpose

Solitary Fibrous Tumor

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Eribulin
Sponsored by
Italian Sarcoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solitary Fibrous Tumor focused on measuring Solitary Fibrous Tumor, soft tissue sarcoma, rare sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera Universitaria Paolo GiacconeRecruiting
  • Policlinico Universitario Campus BiomedicoRecruiting
  • Fondazione IRCCS INT MilanoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eribulin

Arm Description

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.

Outcomes

Primary Outcome Measures

RECIST 1.1 Overall response rate
Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1

Secondary Outcome Measures

Choi Response Rate
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
Survival from the first eribulin dose to death for any cause
Progression Free Survival (PFS) at 3 years
Survival without disease progression
Clinical Benefit Rate
Proportion of patients with no disease progression after 18 weeks of therapy.
Safety of the treatment in term of adverse event
Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0

Full Information

First Posted
February 11, 2019
Last Updated
September 12, 2023
Sponsor
Italian Sarcoma Group
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03840772
Brief Title
Eribulin in Advanced Solitary Fibrous Tumor
Acronym
ERASING
Official Title
ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Sarcoma Group
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Fibrous Tumor
Keywords
Solitary Fibrous Tumor, soft tissue sarcoma, rare sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Not controlled, single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eribulin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Intervention under investigation
Intervention Description
Treatment with eribulin
Primary Outcome Measure Information:
Title
RECIST 1.1 Overall response rate
Description
Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1
Time Frame
At week 6
Secondary Outcome Measure Information:
Title
Choi Response Rate
Description
Proportion of patients with tumor size reduction ⩾10% or a decrease in tumour attenuation⩾15% measured with Choi criteria
Time Frame
At week 6
Title
Overall Survival (OS) at 3 years
Description
Survival from the first eribulin dose to death for any cause
Time Frame
At 3 years
Title
Progression Free Survival (PFS) at 3 years
Description
Survival without disease progression
Time Frame
At 3 years
Title
Clinical Benefit Rate
Description
Proportion of patients with no disease progression after 18 weeks of therapy.
Time Frame
At week 18
Title
Safety of the treatment in term of adverse event
Description
Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0
Time Frame
Week 9, week 18, week 27, week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Stacchiotti, MD
Phone
0039022390
Ext
2803
Email
silvia.stacchiotti@istitutotumori.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Noemi Simone, MD
Phone
0039022390
Ext
2803
Email
noemi.simone@istitutotumori.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD
Organizational Affiliation
Fondazione IRCCS INT di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Paolo Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Badalamenti, MD
Phone
0039091655
Ext
4513
Email
giuseppebadalamenti@unipa.it
First Name & Middle Initial & Last Name & Degree
Badalamenti
First Name & Middle Initial & Last Name & Degree
Giuseppe Badalamenti, MD
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, MD
Phone
+3902225411123
Email
b.vincenzi@unicampus.it
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, MD
Facility Name
Fondazione IRCCS INT Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD
Phone
+39022390
Ext
2804
Email
silvia.stacchiotti@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Eribulin in Advanced Solitary Fibrous Tumor

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