Advanced Solitary Fibrous Tumor (SFT) MedDRA version: 20.0 Level: HLT Classification code 10041298 Term: Soft tissue sarcomas histology unspecified System Organ Class: 100000004864
Conditions
Interventions
Trade Name: HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
Product Name: Eribulina
Product Code: [30058]
Pharmaceutical Form: Solution for injection
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 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 2 (24). Medical history of a myocardial infarction CTCAE Grade 2. 19. Expected non-compliance to medical regimens 20. Subjects with known central nervous system (CNS) metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the activity of eribulin in 2nd or 3rd line, in adult patients with advanced SFT. Therefore, with reference to a study population of patients with progressive locally advanced or metastatic SFT pretreated with one or two line of medical treatment, the primary end-point of the study will be to assess: Overall tumor Response Rate, according to RECIST v 1.1 ;Secondary Objective: 1. Choi Response Rate 2. Overall Survival (OS) 3. Progression Free Survival (PFS) 4. Clinical Benefit Rate 5. Duration of response 6. Safety ;Primary end point(s): Overall tumor Response Rate, according to RECIST v 1.1 : Portion of patients with a tumor size reduction according RECIST ;Timepoint(s) of evaluation of this end point: Evaluated from the time of initial response until documented tumor progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Choi Response Rate 2. Overall Survival (OS) 3. Progression Free Survival (PFS) 4. Clinical Benefit Rate 5. Duration of response 6. Safety;Timepoint(s) of evaluation of this end point: 1) Evaluated from the time of initial response until documented tumor progression according Choi Criteria 2)Evaluated from the time of trial entrance to death for any cause (at 3 and 5 years) 3)Evaluated from the time of treatment start to the first documented PD (every 6 weeks) 4) Evaluated from the time of treatment start to its end (every 3 weeks) 5) Evaluated from the time of the first response to progression (every 6 weeks) 6) Evaluated from the time of treatment start to its end (every 3 weeks) | — |
Countries
Italy
Contacts
Public ContactClinical Trial Unit
Italian Sarcoma Group
Outcome results
None listed