Clinical trial NCT00726323: A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Official title: A Phase II Study of the c-MET RTK Inhibitor XL880 in Subjects With Papillary Renal-Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: c-Met
Papillary Renal Cell Carcinoma(PRC)
Sporadic papillary renal cell carcinoma,
Clear cell renal carcinoma
Hereditary papillary renal cell carcinoma,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
timeFrame: At the end of forth year
Secondary outcomes:
measure: Disease Stabilization Rate Over Period
timeFrame: Up to 4 years
measure: Progression Free Survival (PFS)
timeFrame: At the end of forth year
measure: Time to Response (TTR) Over Period
timeFrame: Up to 4 years
measure: Duration of Response (DOR)
timeFrame: Up to 4 years
measure: Duration of Stable Disease (SD)
timeFrame: Up to 4 years
measure: Overall Survival
timeFrame: Up to 4 years
measure: Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period
timeFrame: Up to 4 years
measure: Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)
timeFrame: Up to 4 years
measure: Number of Participants With Adverse Events, Serious Adverse Events, and Deaths
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Stanford
country: United States
facility: GSK Investigational Site
state: California
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: New Brunswick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Choueiri TK, Vaishampayan U, Rosenberg JE, Logan TF, Harzstark AL, Bukowski RM, Rini BI, Srinivas S, Stein MN, Adams LM, Ottesen LH, Laubscher KH, Sherman L, McDermott DF, Haas NB, Flaherty KT, Ross R, Eisenberg P, Meltzer PS, Merino MJ, Bottaro DP, Linehan WM, Srinivasan R. Phase II and biomarker study of the dual MET/VEGFR2 inhibitor foretinib in patients with papillary renal cell carcinoma. J Clin Oncol. 2013 Jan 10;31(2):181-6. doi: 10.1200/JCO.2012.43.3383. Epub 2012 Dec 3.