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


Phase 2
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.

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Trial Information

Phase II Study of Single-agent Pazopanib (VotrientĀ®) 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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