A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

Completed · Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

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 renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Key facts

Study ID

NCT00726323

Run by

GlaxoSmithKline

People needed

74

Starts

2006-06-30

Expected to finish

2010-08-18

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Greenbrae, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — New Brunswick, New Jersey, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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