Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-17

Study Completion Date

2016-07-27

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.

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Detailed Description

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Conditions

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Germ Cell Tumors Measurable Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pazopanib

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.

Group Type EXPERIMENTAL

Pazopanib

Intervention Type DRUG

Interventions

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Pazopanib

Intervention Type DRUG

Other Intervention Names

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Votrient

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.

* Concurrent treatment with other cytotoxic drugs or targeted therapies.
* Prior radiation therapy within 14 days of trial start.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No