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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pazopanib | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazopanib | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | To evaluate the proportion of patients who are progression-free after 3 months of pazopanib. | 3-months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Mi | 20133 | Italy |
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| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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| 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 |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |