Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Male
Germ Cell Tumors, Measurable Disease, Relapse or Progression After 2 or 3 Chemotherapy Regimens., Relapse or Progression After High-dose Chemotherapy.
Male
Germ Cell Tumors, Measurable Disease, Relapse or Progression After 2 or 3 Chemotherapy Regimens., Relapse or Progression After High-dose Chemotherapy.
Trial Information
Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
Outcome Time Frame:
3-months
Safety Issue:
No
Authority:
Italy: The Italian Medicines Agency
Study ID:
INT123/12
NCT ID:
NCT01743482
Start Date:
January 2013
Completion Date:
April 2015
Related Keywords:
- Germ Cell Tumors
- Measurable Disease
- Relapse or Progression After 2 or 3 Chemotherapy Regimens.
- Relapse or Progression After High-dose Chemotherapy.
- Testicular Cancer
- Germ Cell Tumors
- Salvage Therapy
- Pazopanib
- Recurrence
- Neoplasms, Germ Cell and Embryonal
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