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

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ClinicalTrials.gov Identifier: NCT01743482
Recruitment Status : Unknown
Verified December 2012 by Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Not yet recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (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).
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib
U.S. FDA Resources

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 Name: Votrient



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 3-months ]
    To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.


Secondary Outcome Measures :
  1. Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 3 months ]
  2. Response Rate [ Time Frame: 3 months ]
    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. Overall survival (OS) [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

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

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