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Completed

NCT Number: NCT01743482

Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

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.

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Key information

Conditions

Germ Cell Tumors Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Measurable Disease Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pazopanib

Drug

Other names: Votrient

Primary outcomes

  1. Progression Free Survival

    Time frame: 3-months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: Pazotest-01

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 6, 2012
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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