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

July 29, 2008
June 14, 2012
March 2007
November 2009   (final data collection date for primary outcome measure)
  • 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 ]
To determine the objective response rate (RECIST) of GSK1363089 on 2 different dosing regimens , to evaluate the safety and tolerability of GSK1363089 on 2 different dosing regimens
Complete list of historical versions of study NCT00725712 on ClinicalTrials.gov Archive Site
  • 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 ]
To evaluate progression free survival (PFS), duration of response, and overall survival, to characterize pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089
Not Provided
Not Provided
 
Study of GSK1363089 in Metastatic Gastric Cancer
A Phase 2 Study of GSK1363089 (XL880) Administered Orally to Subjects With Metastatic Gastric Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms, Gastrointestinal Tract
Drug: GSK1363089 (formerly XL880)
c-MET tyrosine kinase inhibitor
Other Name: foretinib
  • Experimental: 5-days on/9-days off
    Dosing for first 5 days in every 14-day period.
    Intervention: Drug: GSK1363089 (formerly XL880)
  • Experimental: daily dosing
    dosed every day
    Intervention: Drug: GSK1363089 (formerly XL880)
Shah MA, Wainberg ZA, Catenacci DV, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Phase II study evaluating 2 dosing schedules of oral foretinib (GSK1363089), cMET/VEGFR2 inhibitor, in patients with metastatic gastric cancer. PLoS One. 2013;8(3):e54014. doi: 10.1371/journal.pone.0054014. Epub 2013 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00725712
MET111643
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP