Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Conditions
Germ Cell Tumors - Measurable Disease - Relapse or Progression After 2 or 3 Chemotherapy Regimens. - Relapse or Progression After High-dose Chemotherapy.
Conditions: official terms
Disease Progression - Neoplasms, Germ Cell and Embryonal
Conditions: Keywords
Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pazopanib
Type: Drug
Overall Status
Not yet recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Male
Criteria: 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.
Location
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Mi, Italy
Status: Not yet recruiting
Contact: Andrea Necchi, MD - +39 02 2390 2402 - andrea.necchi@istitutotumori.mi.it
Start Date
January 2013
Completion Date
April 2015
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Source
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page