Last updated: 11/04/2018 09:12:41

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

Request patient level data
GSK study ID
MET111644
See study documents
Clinicaltrials.gov ID
NCT00726323
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-18-08
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20892
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37232
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Will Be Recruiting
    Contact us
    Showing 1 - 6 of 12 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website