Trial in advanced Solitary Fibrous Tumor (SFT)

Phase 1

• Conditions: Advanced Solitary Fibrous Tumor (SFT); MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004571-12-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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 <=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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 <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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified