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

Primary Purpose

Germ Cell Tumors, Measurable Disease

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Pazopanib
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Germ Cell Tumors focused on measuring Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pazopanib

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2012
Last Updated
May 12, 2021
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01743482
Brief Title
Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Acronym
Pazotest-01
Official Title
Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2013 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumors, Measurable Disease
Keywords
Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pazopanib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Votrient
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
Time Frame
3 months
Title
Response Rate
Description
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
Title
Overall survival (OS)
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Mi
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

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