Phase II study on Regorafenib in advanced Solitary Fibrous Tumor
- Conditions
- Solitary Fibrous TumorMedDRA version: 20.0Level: PTClassification code 10068771Term: Soft tissue neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002629-21-IT
- Lead Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
- Histological centrally confirmed diagnosis of solitary fibrous tumor
- 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); PT-INR/PTT <1.5 x upper limit of normal (Patients who are being therapeutically anti-coagulated 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
- 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.
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 10
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Overall tumor Response Rate, according to Choi criteria extended even to MRI;Secondary Objective: RECIST response rate<br>Overall Survival<br>Progression Free Survival<br>Clinical Benefit Rate<br>Safety<br>;Primary end point(s): Overall tumor Response Rate, according to Choi criteria extended even to MRI;Timepoint(s) of evaluation of this end point: 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): RECIST response rate; Overall Survival; progression free survivol; Clinical Benefit Rate; Safety;Timepoint(s) of evaluation of this end point: 3 years; 6 years; 6 years; 6 months; 6 years