A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
A Phase II Study of the c-MET RTK Inhibitor XL880 in Subjects With Papillary Renal-Cell Carcinoma
1 other identifier
interventional
74
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2006
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2006
CompletedFirst Submitted
Initial submission to the registry
July 29, 2008
CompletedFirst Posted
Study publicly available on registry
July 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2010
CompletedResults Posted
Study results publicly available
December 11, 2017
CompletedDecember 11, 2017
September 1, 2017
4.1 years
July 29, 2008
September 28, 2017
November 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.
At the end of forth year
Secondary Outcomes (9)
Disease Stabilization Rate Over Period
Up to 4 years
Progression Free Survival (PFS)
At the end of forth year
Time to Response (TTR) Over Period
Up to 4 years
Duration of Response (DOR)
Up to 4 years
Duration of Stable Disease (SD)
Up to 4 years
- +4 more secondary outcomes
Study Arms (2)
5/9 dosing
EXPERIMENTAL240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.
daily dosing
EXPERIMENTAL80 mg foretinib on a daily dosing regimen
Interventions
treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Greenbrae, California, 94904-2007, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Stanford, California, 94305, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Bethesda, Maryland, 20892, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
New Brunswick, New Jersey, 08901, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Nashville, Tennessee, 37232, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 23213094BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2008
First Posted
July 31, 2008
Study Start
June 30, 2006
Primary Completion
August 18, 2010
Study Completion
August 18, 2010
Last Updated
December 11, 2017
Results First Posted
December 11, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.