Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Recruiting
First Posted : February 15, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Italian Sarcoma Group

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.


Layout table for study information
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)
Primary Purpose: Treatment
Official Title: ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


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 Name: Intervention under investigation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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

  2. Overall Survival (OS) at 3 years [ Time Frame: At 3 years ]
    Survival from the first eribulin dose to death for any cause

  3. Progression Free Survival (PFS) at 3 years [ Time Frame: At 3 years ]
    Survival without disease progression

  4. Clinical Benefit Rate [ Time Frame: At week 18 ]
    Proportion of patients with no disease progression after 18 weeks of therapy.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Silvia Stacchiotti, MD 0039022390 ext 2803 silvia.stacchiotti@istitutotumori.mi.it
Contact: Noemi Simone, MD 0039022390 ext 2803 noemi.simone@istitutotumori.mi.it

Locations
Layout table for location information
Italy
Azienda Ospedaliera Universitaria Paolo Giaccone Not yet recruiting
Palermo, PA, Italy, 90127
Contact: Giuseppe Badalamenti, MD    0039091655 ext 4513    giuseppebadalamenti@unipa.it   
Contact: Badalamenti         
Principal Investigator: Giuseppe Badalamenti, MD         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, RM, Italy, 00128
Contact: Bruno Vincenzi, MD    +3902225411123    b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Not yet recruiting
Candiolo, Torino, Italy, 10060
Principal Investigator: Giovanni Grignani, MD         
Fondazione IRCCS INT Milano Recruiting
Milano, Italy, 20133
Contact: Silvia Stacchiotti, MD    +39022390 ext 2804    silvia.stacchiotti@istitutotumori.mi.it   
Principal Investigator: Silvia Stacchiotti, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Eisai Inc.
Investigators
Layout table for investigator information
Principal Investigator: Silvia Stacchiotti, MD Fondazione IRCCS INT di Milano

Publications:

Layout table for additonal information
Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT03840772     History of Changes
Other Study ID Numbers: ISG-ERASING
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Italian Sarcoma Group:
Solitary Fibrous Tumor
soft tissue sarcoma
rare sarcoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Fibrous Tissue
Solitary Fibrous Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms