Primary or recurrent sporadic desmoid tumor MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: FARESTON*30CPR 60MG
Pharmaceutical Form: Capsule
INN or Proposed INN: TOREMIFENE CITRATE
CAS Number: 89778-27-8
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (age > 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis. - Histologically documented diagnosis of DF. - At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated. - Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST). - Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST. - ECOG Performance status: 0-2. - Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed - Adequate end organ function, defined as the following: total bilirubin 1.5 x 109/L, platelets > 100 x 109/L. - Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic 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 barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - Life expectancy of at least 6 months. - Written, voluntary, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Previous history of deep vein thrombosis. - Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/vRR) or history of familial long QT syndrome. - Previous arrhythmia. - Clinically significant bradycardia. - Endometrial hyperplasia. - Hepatic insufficiency. - Other concurrent hormonal therapy, including hormonal contraceptives. - Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding. - Patient has a severe and/or uncontrolled medical disease. - Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. - Patient received chemotherapy within 4 weeks prior to study entry. - Patient had a major surgery within 2 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of toremifene in terms of tumor response rate and symptom relief in patients with desmoid tumors;Secondary Objective: -Determine the safety of toremifene in patients with sporadic primary or recurrent desmoid tumor -Determine the quality of life of patients treated with toremifene -Identify a correlation between specific marker expression and response to treatment;Primary end point(s): Progression-free survival (PFS) computed for each patient, from the date of toremifene onset to the date of progression or interruption for any cause or to the date of last observation if progression free assessed according to RECIST criteria -Time to pain relief from the date of toremifene onset to the date of pain relief according to visual analog scale (VAS);Timepoint(s) of evaluation of this end point: PFS will be evaluated at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Descriptive evaluation of any adverse events registered from the date of toremifene onset according to the Common Toxicity Criteria for Adverse Events (NCI - CTC) version 4.03 -Descriptive evaluation of quality of life using QLQ-C30 EORTC Questionnaire -Correlation between expression pattern of specific marker/target and response to toremifene treatment;Timepoint(s) of evaluation of this end point: -Adverse events registered during the entire duration of the study -Quality of life: at the accrual and at the progression or end of the study -Correlation between markers expression and response at the end | — |
Countries
Italy
Contacts
Public Contact-
ISTITUTO NAZIONALE PER LA CURA DEI TUMORI
Outcome results
None listed