Brief Title
Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Official Title
Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression Free Survival
Secondary Outcome
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
Condition
Germ Cell Tumors
Intervention
Pazopanib
Study Arms / Comparison Groups
Pazopanib
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
43
Start Date
May 17, 2013
Completion Date
July 27, 2016
Primary Completion Date
July 27, 2016
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.
Gender
Male
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01743482
Organization ID
INT123/12
Responsible Party
Principal Investigator
Study Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
GlaxoSmithKline
Study Sponsor
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Verification Date
May 2021