Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors (Pazotest-01)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase: Completed; Phase 2

Conditions: Germ Cell Tumors; Measurable Disease

Treatments: Drug: Pazopanib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01743482

INT123/12

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Pazopanib

Experimental group

Description:

Patients will receive pazopanib at the dose of 800 mg/day orally until disease progression or evidence of unacceptable toxicity/side effects. The study will be performed according to Simon's two-stage optimal design.

Treatment:

Drug: Pazopanib