ERibulin in Advanced Solitary fibrous tumor, an ItaliaN sarcoma Group phase II study (ERASING)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Italian Sarcoma Group

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jun 2019 → 13 Oct 2025

Decision date (initial)

2024-10-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

EISAI

External identifiers

EU CT number

2024-517795-38-00

EudraCT number

2018-004571-12

ClinicalTrials.gov

NCT03840772

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety, Others

The primary objective of this study is to explore the activity of eribulin in 2nd or 3rd line, in adult patients with advanced Solitary Fibrous Tumour.

Secondary objectives 1

1. The activity of eribulin in advanced SFT will be also evaluated according to Choi criteria. In addition, eribulin efficacy will be investigated by means of progression-free survival (PFS), clinical benefit rate (RECIST CR + PR + SD > 6 months), overall survival (OS) and duration of response. The toxicity profile of eribulin will be also evaluated

Conditions and MedDRA coding

Advanced Solitary fibrous tumor

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses
2. Age ≥18 years
3. Histological centrally and molecularly confirmed diagnosis of STAT6 positive solitary fibrous tumor (inclusive of the last available tumor sample or fresh biopsy); a paraffin embedded tumor block is required.
4. Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
5. Measurable or evaluable disease with RECIST 1.1
6. Evidence of progression by RECIST 1.1 during the 6 months before study entry
7. Patients must be pre-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% as measured by echocardiogram
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 20

1. Naïve patients
2. >2 line 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 (24). 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 QTc interval prolongation of more than or equal to 501 msec on at least two separate electrocardiograms (ECGs), 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 (NCI‐CTCAE v 5.0) 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, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy (see Exclusion 18) and alopecia.
18. Pre-existing peripheral neuropathy > CTCAE Grade 2.
19. Expected non-compliance to medical regimens
20. Subjects with known central nervous system (CNS) metastases.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall tumor Response Rate, according to RECIST v 1.1

Secondary endpoints 6

1. Choi Response Rate
2. Overall Survival (OS)
3. Progression Free Survival (PFS)
4. Clinical Benefit Rate
5. Duration of response
6. Safety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Italian Sarcoma Group

Sponsor organisation

Italian Sarcoma Group

Address

Via Luigi Carlo Farini 31

City

Bologna

Postcode

40124

Country

Italy

Scientific contact point

Organisation

Italian Sarcoma Group

Contact name

Silvia Stacchiotti

Public contact point

Organisation

Italian Sarcoma Group

Contact name

Gianluca Ignazzi

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications