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Phase II study on Regorafenib in advanced SOlitary Fibrous Tumor SOFT - Solitary fibrous tumor (SFT)

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

· 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
· Measurable or evaluable disease with Choi criteria
· Evidence of progression by Choi during the 6 months before study entry
· 1st, 2nd or 3rd line
· Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
· Adequate bone marrow function, defined as the following: WBC >3.0 x 109/L,ANC >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL and blood transfusions to reach the baseline requested Hb level are not allowed
· Adequate organ function, defined as the following: total bilirubin <1.5 times the upper limit of normal (except in case of Gilbert’s syndrome), AST (SGOT) and ALT (SGPT) <2.5 x UNL, Lipase ≤ 1.5 x the ULN, creatinine <1.5 x ULN. within normal institutional limits or creatinine clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; alkaline phosphatase <2.5 x ULN (<5 x upper limit of normal for patients with liver involvement of their cancer and/or have bone metastases); PTINR/PTT <1.5 x upper limit of normal (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists).
· Cardiac ejection fraction ≥50% as measured by echocardiogram
· Age > 18 yrs
· 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 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 and for up to 3 months following discontinuation of study drug.
· No history of arterial and/or venous thromboembolic event within the previous 12 months.
. Written, voluntary informed consent'

Criteri di esclusione: 

Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing.
· Prior treatment with >3 lines of anticancer agents
· 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
· 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 administered more than 4 weeks earlier
· Major surgery within 4 weeks prior to study entry
· Pregnancy
· Brest feeding
· Inability to swallow oral tablets (crushing of study treatment tablets is not allowed)
· Evidence of congestive heart failure classified as New York Heart Association Class 2 or higher
· Evidence of unstable angina (angina symptoms at rest) or new‐onset angina ≤ 3 months prior to screening.
· Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
· Arrhythmias requiring anti‐arrhythmic therapy, with the exception of beta blockers or digoxin
· Uncontrolled hypertension (systolic blood pressure [SBP] > 140 mmHg or diastolic blood pressure [DBP] > 90 mmHg) despite optimal medical management
· 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
· Ongoing infection with severity of Grade 2 or above (NCICTCAE v 4.0)
· Known history of human immunodeficiency virus infection
· Active or chronic hepatitis B or C requiring treatment with antiviral therapy
· History of organ allograft
· Evidence or history of any bleeding diathesis (including mild hemophilia), irrespective of severity
· Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI‐CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
· Presence of non‐healing wound, ulcer, or bone fracture
· Renal failure requiring hemodialysis or peritoneal dialysis
· Dehydration ≥ Grade 1 (NCI‐CTCAE v 4.0)
· Interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained
· Persistent proteinuria > 3.5 g/24 hours measured by urine protein creatinine ratio from a random urine sample (≥ Grade 3, NCICTCAE v 4.0)
· 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
· Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
· Presence of any malabsorption condition
· Previous radiotherapy to 25 % of the bone marrow
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Regorafenib
· Expected non-compliance to medical regimens

 

Trattamento sperimentale: 

Regorafenib

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Dr.ssa Silvia Stacchiotti
Telefono: 0223902803
Email: silvia.stacchiotti@istitutotumori.mi.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NA

Data di inserimento: 23.11.2017

Promotore

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

CRO

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Dr.ssa Silvia Stacchiotti

Telefono: 0223902803

Email: silvia.stacchiotti@istitutotumori.mi.it

Localita: Milano

 

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