Status:
COMPLETED
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary re...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of \</= 2.
- Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
Exclusion
- Radiation to \>/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,
- Any uncontrolled intercurrent illness,
- Pregnant or breastfeeding,
- HIV positive
Key Trial Info
Start Date :
June 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2010
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00726323
Start Date
June 30 2006
End Date
August 18 2010
Last Update
December 11 2017
Active Locations (12)
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1
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
2
GSK Investigational Site
San Francisco, California, United States, 94115
3
GSK Investigational Site
Stanford, California, United States, 94305
4
GSK Investigational Site
Indianapolis, Indiana, United States, 46202