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A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma


Inclusion Criteria:



- Histologically confirmed diagnosis of PRC with metastatic disease or bilateral
multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance
status of
- Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best confirmed tumor response rate

Outcome Description:

Primary efficacy

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

MET111644

NCT ID:

NCT00726323

Start Date:

June 2006

Completion Date:

July 2012

Related Keywords:

  • Carcinoma, Renal Cell
  • c-Met
  • Papillary Renal Cell Carcinoma(PRC)
  • Sporadic papillary renal cell carcinoma,
  • Clear cell renal carcinoma
  • Hereditary papillary renal cell carcinoma,
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Baltimore, Maryland  21201
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site Pittsburgh, Pennsylvania  15213