Phase II Study of Axitinib in Advanced Solitary Fibrous Tumor

Active, not recruiting

Conditions: Advanced solitary fibrous tumor
MedDRA version: 16.1Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-005596-40-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: Not specified

Inclusion Criteria

•Histological centrally confirmed diagnosis of solitary fibrous tumor

•Expression of PDGFRB and/or VEGFR2 by immunohistochemistry on formalin fixed-paraffin embedded (FFPE) material as minimal requirement. Activation of PDGFRB and/or VEGFR2 by real time PCR of PDGFB and VEGFA on FFPE material (if in sufficient quantity) or by biochemistry on frozen material (if available).

•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

•Evidence of progression by RECIST during the 6 months before study entry

•1st-line vs 3-rd-line

•Eastern Cooperative Oncology Group (ECOG) Performance Status = 0, 1, 2

•Adequate bone marrow function, defined as the following: ANC >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level

•Adequate organ function, defined as the following: total bilirubin within normal institutional limits (but in case of Gilbert’s syndrome), AST (SGOT) and ALT (SGPT) <2.5 x UNL, 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

•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 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 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

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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•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 any other investigational or not investigational agents and or radiation therapy within 28 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 2 weeks prior to study entry

•Previous radiotherapy to ?25 % of the bone marrow

•Concomitant other investigational agents or concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded

•Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., history of uncontrolled or symptomatic angina, history of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit)

•Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)

•Known diagnosis of human immunodeficiency virus (HIV) infection

•History of allergic reactions attributed to compounds of similar chemical or biologic composition to Axitinib

•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 ;Secondary Objective: RECIST response rate<br>Overall Survival<br>Progression Free Survival<br>Clinical Benefit<br>Post-treatment Axitinib target status assessment<br>;Primary end point(s): Overall tumor Response Rate, according to Choi ;Timepoint(s) of evaluation of this end point: 4 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): RECIST response rate<br>Overall Survival<br>Progression Free Survival<br>Clinical Benefit<br>Post-treatment Axitinib target status assessment<br>;Timepoint(s) of evaluation of this end point: 4 years