Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor

Solitary Fibrous Tumor Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. The activity of Axitinib will be evaluated in terms of overall response rate according to Choi Criteria as defined for GIST patients treated with Imatinib, extended even to MRI. Secondary objectives of the study will be: response rate by RECIST, progression free survival, overall survival, clinical benefit (RECIST Complete Response + Partial Response + Stable Disease >6 months). Whenever possible a post-treatment biopsy will be performed to assess Axitinib targets status after treatment and to correlate their status to the response. Tumor assessment with CT scan and/or MRI will be performed within 4 weeks prior to first dose of Axitinib and after 4 weeks from starting treatment, then every 2 months until progression or toxicity. As per protocol the experimental treatment can be administered in front or further line. The study will be considered positive if 30% of response rate by Choi criteria is observed. To this end a maximum of 16 evaluable patients will be enrolled in two years. In case of positive study the trial will be re-open to confirm the result in a larger number of patients. . ;

Related Conditions & MeSH terms

• Solitary Fibrous Tumor
• Solitary Fibrous Tumors

• NCT number: NCT02261207
• Study type: Interventional
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: March 2018