Clinical trial · Interventional
Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
NCT01743482CI-TRIAL-00051801Pazotest-01completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumors | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Measurable Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 3-months
- description
- To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
Secondary outcomes (3)
- measure
- Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.