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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Completed
CT.gov ID
NCT01743482
Collaborator
GlaxoSmithKline (Industry)
43
Enrollment
1
Location
1
Arm
38.3
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
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).
Actual Study Start Date :
May 17, 2013
Actual Primary Completion Date :
Jul 27, 2016
Actual Study Completion Date :
Jul 27, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [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 [3 months]

    2. Response Rate [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Mi Italy 20133

    Sponsors and Collaborators

    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    • GlaxoSmithKline

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Necchi, Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    ClinicalTrials.gov Identifier:
    NCT01743482
    Other Study ID Numbers:
    • INT123/12
    First Posted:
    Dec 6, 2012
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Andrea Necchi, Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    Testicular Cancer
    Germ Cell Tumors
    Salvage Therapy
    Pazopanib
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of May 14, 2021