Clinical trial · Interventional
Eribulin in Advanced Solitary Fibrous Tumor
ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)
NCT03840772CI-TRIAL-00080915ERASINGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solitary Fibrous Tumor | Solitary Fibrous Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin
- 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.
- interventionNames
- Drug: Eribulin
Primary outcomes (1)
- measure
- RECIST 1.1 Overall response rate
- timeFrame
- At week 6
- description
- Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1
Secondary outcomes (5)
- measure
- Choi Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDVerbeke SL, Fletcher CD, Alberghini M, Daugaard S, Flanagan AM, Parratt T, Kroon HM, Hogendoorn PC, Bovee JV. A reappraisal of hemangiopericytoma of bone; analysis of cases reclassified as synovial sarcoma and solitary fibrous tumor of bone. Am J Surg Pathol. 2010 Jun;34(6):777-83. doi: 10.1097/PAS.0b013e3181dbedf1. PMID 20421780
- BACKGROUNDRobinson DR, Wu YM, Kalyana-Sundaram S, Cao X, Lonigro RJ, Sung YS, Chen CL, Zhang L, Wang R, Su F, Iyer MK, Roychowdhury S, Siddiqui J, Pienta KJ, Kunju LP, Talpaz M, Mosquera JM, Singer S, Schuetze SM, Antonescu CR, Chinnaiyan AM. Identification of recurrent NAB2-STAT6 gene fusions in solitary fibrous tumor by integrative sequencing. Nat Genet. 2013 Feb;45(2):180-5. doi: 10.1038/ng.2509. Epub 2013 Jan 13. PMID 23313952
- BACKGROUNDDagrada GP, Spagnuolo RD, Mauro V, Tamborini E, Cesana L, Gronchi A, Stacchiotti S, Pierotti MA, Negri T, Pilotti S. Solitary fibrous tumors: loss of chimeric protein expression and genomic instability mark dedifferentiation. Mod Pathol. 2015 Aug;28(8):1074-83. doi: 10.1038/modpathol.2015.70. Epub 2015 May 29. PMID 26022454
- BACKGROUNDChamberlain MC, Glantz MJ. Sequential salvage chemotherapy for recurrent intracranial hemangiopericytoma. Neurosurgery. 2008 Oct;63(4):720-6; author reply 726-7. doi: 10.1227/01.NEU.0000325494.69836.51. PMID 18981882
- BACKGROUNDGalanis E, Buckner JC, Scheithauer BW, Kimmel DW, Schomberg PJ, Piepgras DG. Management of recurrent meningeal hemangiopericytoma. Cancer. 1998 May 15;82(10):1915-20. PMID 9587125
- BACKGROUNDBeadle GF, Hillcoat BL. Treatment of advanced malignant hemangiopericytoma with combination adriamycin and DTIC: a report of four cases. J Surg Oncol. 1983 Mar;22(3):167-70. doi: 10.1002/jso.2930220306. PMID 6682161
- BACKGROUNDStacchiotti S, Libertini M, Negri T, Palassini E, Gronchi A, Fatigoni S, Poletti P, Vincenzi B, Dei Tos AP, Mariani L, Pilotti S, Casali PG. Response to chemotherapy of solitary fibrous tumour: a retrospective study. Eur J Cancer. 2013 Jul;49(10):2376-83. doi: 10.1016/j.ejca.2013.03.017. Epub 2013 Apr 6.