Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Germ Cell Tumors Measurable Disease

Interventions

PazopanibDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, Italy

Outcomes

Primary Outcomes

Progression Free Survival

To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.

Time frame: 3-months

Secondary Outcomes

Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03

Time frame: 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

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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