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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00726323
First received: July 29, 2008
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Carcinoma, Renal Cell
Drug: foretinib (formerly GSK1363089 or XL880)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Best confirmed tumor response rate [ Time Frame: 4 years ]
    Primary efficacy


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 4 years ]
    Efficacy secondary endpoint

  • time to response [ Time Frame: 4 years ]
    efficacy

  • duration of response [ Time Frame: 4 years ]
    efficacy

  • Duration of stable disease [ Time Frame: 4 years ]
    efficacy

  • Overall survival [ Time Frame: 4 years ]
    efficacy

  • Laboratory tests [ Time Frame: 4 years ]
    Safety

  • Adverse events [ Time Frame: 4 years ]
    Safety


Enrollment: 74
Study Start Date: June 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5/9 dosing
240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.
Drug: foretinib (formerly GSK1363089 or XL880)
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
Other Name: GSK1363089 (formerly XL880)
Experimental: daily dosing
80 mg foretinib on a daily dosing regimen
Drug: foretinib (formerly GSK1363089 or XL880)
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
Other Name: GSK1363089 (formerly XL880)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726323

Locations
United States, California
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
GSK Investigational Site
San Francisco, California, United States, 94115
GSK Investigational Site
Stanfore, California, United States, 94305
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, New Jersey
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: MET111644
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00726323     History of Changes
Obsolete Identifiers: NCT00345423
Other Study ID Numbers: MET111644 
Study First Received: July 29, 2008
Last Updated: November 30, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
c-Met
Papillary Renal Cell Carcinoma(PRC)
Sporadic papillary renal cell carcinoma,
Clear cell renal carcinoma
Hereditary papillary renal cell carcinoma,

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on January 19, 2017