Last updated: 11/04/2018 09:12:41
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase II Study of the c-MET RTK Inhibitor XL880 in Subjects with Papillary Renal-Cell Carcinoma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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:
Disease stabilization rate over period
Timeframe: Up to 4 years
Progression free survival (PFS)
Timeframe: At the end of forth year
Time to response (TTR) over period
Timeframe: Up to 4 years
Duration of response (DOR)
Timeframe: Up to 4 years
Duration of stable disease (SD)
Timeframe: Up to 4 years
Overall survival
Timeframe: Up to 4 years
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
Number of participants with change in CTCAE grade of hematological parameters over period (only worst case)
Timeframe: Up to 4 years
Number of participants with adverse events, serious adverse events, and deaths
Timeframe: Up to 4 years
Interventions:
Drug: foretinib (formerly GSK1363089 or XL880)
Enrollment:
74
Observational study model:
Not applicable
Primary completion date:
2010-18-08
Time perspective:
Not applicable
Clinical publications:
Choueiri TK, Vaishampayan U, Rosenberg J, Logan T, Harzstark A, Bukowski R, Rini B, Srinivas S, Stein M, Adams L, Ottesen L, Laubscher K, Sherman L, McDermott D, Haas N, Ross R, Eisenber, P, Meltzer PS, Merino MJ, Bottaro DP, Linehan WM, Srinivasan R. A Phase II and Biomarker Study of the dual MET/VEGFR-2 inhibitor Foretinib in Patients with Papillary Renal-Cell Carcinoma. J Clin Oncol. 2013;31(2):181-186.
Medical condition
Carcinoma, Renal Cell
Product
foretinib
Collaborators
Not applicable
Study date(s)
June 2006 to August 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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,
Inclusion and exclusion 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
- 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
Trial location(s)
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20892
Status
Will Be Recruiting
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Will Be Recruiting
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Will Be Recruiting
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Will Be Recruiting
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Will Be Recruiting
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Will Be Recruiting
Location
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stanfore, California, United States, 94305
Status
Will Be Recruiting
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-18-08
Actual study completion date
2010-18-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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