Eribulin in Advanced Solitary Fibrous Tumor

NCT03840772 | Completed Phase 2

• 1 other identifier: ISG-ERASING
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Solitary Fibrous Tumor

Keywords

Solitary Fibrous Tumor; soft tissue sarcoma; rare sarcoma

Outcome Measures

Primary Outcomes (1)

• RECIST 1.1 Overall response rate

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

  At week 6

Secondary Outcomes (5)

• Choi Response Rate

  At week 6

• Overall Survival (OS) at 3 years

  At 3 years

• Progression Free Survival (PFS) at 3 years

  At 3 years

• Clinical Benefit Rate

  At week 18

• Safety of the treatment in term of adverse event

  Week 9, week 18, week 27, week 36

Study Arms (1)

Eribulin

EXPERIMENTAL

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

Interventions

Eribulin DRUG

Treatment with eribulin

Also known as: Intervention under investigation

Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead
• Eisai Inc.: collaborator

Study Sites (3)

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, RM, 00128, Italy

Location

Fondazione IRCCS INT Milano

Milan, 20133, Italy

Location

Related Publications (11)

• Verbeke 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 BACKGROUND

• Robinson 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 BACKGROUND

• Dagrada 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 BACKGROUND

• Chamberlain 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 BACKGROUND

• Galanis 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 BACKGROUND

• Beadle 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 BACKGROUND

• Stacchiotti 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.

  PMID: 23566418 BACKGROUND

• Schoffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

  PMID: 26874885 BACKGROUND

• Schoffski P, Ray-Coquard IL, Cioffi A, Bui NB, Bauer S, Hartmann JT, Krarup-Hansen A, Grunwald V, Sciot R, Dumez H, Blay JY, Le Cesne A, Wanders J, Hayward C, Marreaud S, Ouali M, Hohenberger P; European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011 Oct;12(11):1045-52. doi: 10.1016/S1470-2045(11)70230-3. Epub 2011 Sep 19.

  PMID: 21937277 BACKGROUND

• Kawai A, Araki N, Naito Y, Ozaki T, Sugiura H, Yazawa Y, Morioka H, Matsumine A, Saito K, Asami S, Isu K. Phase 2 study of eribulin in patients with previously treated advanced or metastatic soft tissue sarcoma. Jpn J Clin Oncol. 2017 Feb 1;47(2):137-144. doi: 10.1093/jjco/hyw175.

  PMID: 28173193 BACKGROUND

• Van Glabbeke M, Verweij J, Judson I, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002 Mar;38(4):543-9. doi: 10.1016/s0959-8049(01)00398-7.

  PMID: 11872347 BACKGROUND

MeSH Terms

Conditions

Solitary Fibrous Tumors; Sarcoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Silvia Stacchiotti, MD

  Fondazione IRCCS INT di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Not controlled, single arm study

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: July 17, 2019
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)