Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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Germ Cell Tumors, Measurable Disease

Intervention / Treatment
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* Drug: Pazopanib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pazopanib<br>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. | Drug: Pazopanib<br> <br> * Other names: Votrient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | To evaluate the proportion of patients who are progression-free after 3 months of pazopanib. | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03 |  | 3 months | 
| Response Rate | A response rate will be considered as the sum of complete (CR) and partial responses (PR) according to the response evaluation criteria in solid tumors (RECIST), version 1.1 | 3 months | 
| Overall survival (OS) | OS time will be calculated as the interval from treatment start date to the date of death for any cause, with censoring at the date of last contact for patients alive. The Kaplan-Meier method will be used to estimate the OS curve. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib