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

This study is not yet open for participant recruitment.
Verified December 2012 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01743482
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Germ Cell Tumors
Measurable Disease
Relapse or Progression After 2 or 3 Chemotherapy Regimens.
Relapse or Progression After High-dose Chemotherapy.
 Drug: Pazopanib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Pazopanib
U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Response Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 43
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Votrient

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743482

Contacts
Contact: Andrea Necchi, MD +39-02-2390-2402 andrea.necchi@istitutotumori.mi.it

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milano, Mi, Italy, 20133
Contact: Andrea Necchi, MD     +39 02 2390 2402     andrea.necchi@istitutotumori.mi.it    
Sub-Investigator: Patrizia Giannatempo, MD            
Principal Investigator: Andrea Necchi, MD            
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Andrea Necchi, Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01743482     History of Changes
Other Study ID Numbers: INT123/12
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Testicular Cancer
Germ Cell Tumors
Salvage Therapy
Pazopanib

Additional relevant MeSH terms:
Recurrence
Neoplasms, Germ Cell and Embryonal
Disease Attributes
 Pathologic Processes
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013