Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

Germ Cell Tumors Clinical Trial

— Pazotest-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743482
• Other study ID #: INT123/12
• Status: Completed
• Phase: Phase 2
• Start date: May 17, 2013
• Est. completion date: July 27, 2016

Study information

• Verified date: May 2021
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 27, 2016
• Est. primary completion date: July 27, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Germ Cell Tumors
• Measurable Disease
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• Pazopanib

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	Mi

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.	3-months
Secondary	Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03		3 months
Secondary	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
Secondary	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