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Sunitinib in Refractory or Relapsed Germ Cell Tumors
NCT00453310Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Nov 2008
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Drugs
- sunitinib
- Conditions
- germ cell tumor (GCT)
01
Overview
Phase 2, open-label, single-arm trial of sunitinib in germ cell tumor (GCT), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Objective Response Rate at 12 weeks. Started Mar 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Sunitinib Malate Arm
Single group receiving oral sunitinib malate.
03
Who it enrols
Patients with histologically confirmed metastatic germ cell tumors (seminoma or nonseminoma) that have relapsed or are refractory to cisplatin-based chemotherapy, with measurable disease and adequate organ function.
04
Endpoints
Primary
Objective Response Rate
Secondary
Safety and Tolerability
Time to Tumor Response
Duration of Tumor Response
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