Study of GSK1363089 in Metastatic Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00725712
First received: July 29, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric carcinoma.


Condition Intervention Phase
Neoplasms, Gastrointestinal Tract
Drug: GSK1363089 (formerly XL880)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of GSK1363089 (XL880) Administered Orally to Subjects With Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Objective response rate (RECIST) of GSK1363089 on 2 different dosing regimens [ Time Frame: 4 months (average) ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events, and clinically significant changes in vital signs and laboratory values [ Time Frame: 4 months (average) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median progression free survival (PFS) of GSK1363089 [ Time Frame: 4 months (average) ] [ Designated as safety issue: No ]
  • Duration of Stable Disease of GSK1363089 [ Time Frame: 4 months (average) ] [ Designated as safety issue: No ]
  • Peak and trough concentrations of GSK1363089 in plasma samples [ Time Frame: first 8 weeks of study treatment ] [ Designated as safety issue: No ]
  • Disease stabilization rate of GSK 1363089 [ Time Frame: 4 months (average) ] [ Designated as safety issue: No ]
  • Median overall survival of GSK1363089 [ Time Frame: 6 months (average) ] [ Designated as safety issue: No ]
  • Plasma concentrations of soluble MET, HGF, soluble VEGFR2 and VEGFA [ Time Frame: first 8 weeks of study treatment ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-days on/9-days off
Dosing for first 5 days in every 14-day period.
Drug: GSK1363089 (formerly XL880)
c-MET tyrosine kinase inhibitor
Other Name: foretinib
Experimental: daily dosing
dosed every day
Drug: GSK1363089 (formerly XL880)
c-MET tyrosine kinase inhibitor
Other Name: foretinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed diagnosis of advanced or metastatic gastric carcinoma, or adenocarcinoma of the gastroesophageal junction or of the distal esophagus. Subjects with tumors of the gastroesophageal junction or of the distal esophagus may be eligible provided that the tumor is not of squamous or sarcomatous histology
  • Measurable disease
  • The subject consents to provide paired tumor biopsies, directly prior to commencing study treatment and then between Days 5 and 8.
  • The subject has an ECOG performance status ≤2.
  • The subject is able to ingest the GSK1363089 capsules.
  • In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥20 μg/dL (552 nmol/L) 30-90 minutes after injection of ACTH.
  • The subject has liver, kidney and marrow function.
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
  • Sexually active subjects (male and female) must use a medically-accepted method of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
  • The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago, and has no evidence of disease for 5 years prior to the screening for this study).
  • QTc < 470 msec.

Exclusion Criteria:

  • The subject has received more than two lines of prior cytotoxic chemotherapy for locally advanced or metastatic disease. For the purpose of this protocol, neoadjuvant therapy would not be considered to be prior cytotoxic chemotherapy. In addition, potential subjects who have received prior treatment with c-MET signaling inhibitor are excluded.
  • The subject has received an investigational drug within 14 days of the first dose of study drug.
  • The subject has received chemotherapy, immunotherapy, or radiation therapy (to

    ≥25% of his or her bone marrow) within 14 days or has received nitrosoureas or mitomycin C within 6 weeks prior to the scheduled first dose of GSK1363089.

  • The subject has AEs due to investigational drugs or other medications administered more than 21 days prior to enrollment that have not recovered to Grade ≤1 using NCI CTCAE v3.0, with the exception of alopecia greater than grade 1.
  • The subject has known brain metastases.
  • The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The subject is pregnant or breastfeeding.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject has a previously identified allergy or hypersensitivity to components of the GSK1363089 formulation.
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  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: NCT00725712

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90024
GSK Investigational Site
Stanford, California, United States, 94305
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30309
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Montana
GSK Investigational Site
Billings, Montana, United States, 59101
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, New York
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
New York, New York, United States, 10021
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00725712     History of Changes
Obsolete Identifiers: NCT00415480
Other Study ID Numbers: MET111643
Study First Received: July 29, 2008
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
c-Met
Metastatic Gastric Carcinoma
adenocarcinoma
Gastric cancer
GSK1363089
XL880
MET inhibitor

Additional relevant MeSH terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Stomach Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 28, 2014