Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).

This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.

Inclusion Criteria:

• Male gender.
• Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
• Unequivocal progression of measurable disease.
• A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
• First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
• Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.

Exclusion Criteria:

• Failure to meet any of the above inclusion criteria.
• Concurrent treatment with other cytotoxic drugs or targeted therapies.
• Prior radiation therapy within 14 days of trial start.