Pazopanib in chemoresistant patients with germ cell tumors (GCT): Updated results of the open-label, single-group, phase 2 Pazotest-01 trial.

Abstract

e15529 Background: Patients (pts) with GCT who fail to be cured following multiple chemotherapy (CT) courses (± high-dose CT) have an extremely poor prognosis and long-term remissions are anecdotal. Pazopanib (PZP) is a potent and selective, orally available, TKI of VEGFR1, 2, and 3, PDGFRα, PDGFRβ, and cKit. We updated the initial results of the ongoing open-label, single-group, phase 2 study which is sponsored by INT Milano. Methods: Patients failing at least 2 platinum-based CT (including high-dose CT) received PZP 800 mg/day orally until disease progression (PD) or evidence of unacceptable toxicity/side effects. All pts underwent measurement of serum tumor markers (STM), a computed tomography and a FDG-PET after 1 month and q2 months thereafter. In a Simon’s 2-stage design, the primary endpoint is 3-month progression-free survival (PFS). In stage 1, 18 evaluable patients will be accrued. If ≥ 3 pts will be progression-free at 3 months, enrolment will be extended to the 2ndstage. Results: From 06 to 12...