Solitary Fibrous Tumor MedDRA version: 20.0 Level: PT Classification code 10068771 Term: Soft tissue neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: STIVARGA - 40 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE
Product Name: stivarga
Product Code: BAY 73-4506
Pharmaceutical Form: Tablet
INN or Proposed INN
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall tumor Response Rate, according to Choi criteria extended even to MRI;Secondary Objective: RECIST response rate Overall Survival Progression Free Survival Clinical Benefit Rate Safety ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public Contactclinical trial center
Fondazione IRCCS Istituto dei Tumori
Outcome results
None listed