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Erlotinib in Locally Advanced or Metastatic Papillary Renal Cell Cancer
NCT00060307Phase 2
Key facts
- Status
- Completed
- Start
- May 2003
- Primary completion
- May 2007
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- erlotinib
- Conditions
- papillary renal cell carcinoma (PRCC)
01
Overview
Phase 2, open-label, single-arm trial of erlotinib in papillary renal cell carcinoma (PRCC), sponsored by National Cancer Institute. Primary endpoint: Response Probability up to 3 years. Started May 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (erlotinib)
Patients receive oral erlotinib once daily.
03
Who it enrols
Patients with histologically confirmed metastatic or unresectable locally advanced papillary renal cell carcinoma, measurable disease, and no prior chemotherapy or immunotherapy.
04
Endpoints
Primary
Response Probability
Secondary
Time to Treatment Failure
Overall Survival
Qualitative and Quantitative Toxicities
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