Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors (Pazotest-01)

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

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 Overview

• Status: Completed
• Conditions: Germ Cell Tumors; Measurable Disease
• Intervention / Treatment: Drug: Pazopanib

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milano, Mi, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Pazopanib; Other Names: Votrient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.	3-months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2013
• Primary Completion (Actual): July 27, 2016
• Study Completion (Actual): July 27, 2016

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pazopanib; Salvage Therapy; Germ Cell Tumors; Testicular Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: INT123/12