Phase II Study on Axitinib in Advanced VEGFR and/or PDGFR Solitary Fibrous Tumor

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an investigator initiated, open label, prospective, non-randomized, phase II trial aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pat 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 C reactive protein 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 disease

• Centrally confirmed 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: absolute neutrophil count (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), aspartate aminotransferase (AST) and Serum Glutamic Pyruvic Transaminase (ALT) <2.5 x upper normal limit (UNL), creatinine <1.5 x upper normal limit (UNL), 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Naazionale dei Tumori
Milan
Time Frame
Start Date: November 2014
Completion Date: March 2018
Participants
Target number of participants: 17
Treatments
Experimental: Axitinib
Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov

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