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Study of GSK1363089 in Metastatic Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725712
First Posted: July 30, 2008
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: July 23, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neoplasms, Gastrointestinal Tract
Intervention: Drug: GSK1363089 (formerly XL880)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 74 participants with Metastatic gastric cancer were enrolled in this sequential cohort study at 15 sites in the United States of America. The study was conducted from 23 March 2007 to 20 October 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GSK1363089, Intermittent 5 and 9 Dosing The eligible participants in this arm were administered GSK1363089 at 240 milligram (mg) per dosing day orally, on 5 days on and 9 days off cycle every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose
GSK136308, Daily Dosing The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.

Participant Flow:   Overall Study
    GSK1363089, Intermittent 5 and 9 Dosing   GSK136308, Daily Dosing
STARTED   48   26 
COMPLETED   0   0 
NOT COMPLETED   48   26 
Withdrawal by Subject                2                1 
Protocol Violation                1                0 
Progressive disease                37                16 
Clinical progression not based on RECIST                0                3 
Adverse Event                5                5 
Death                2                0 
Other: Death                1                0 
Hospitalized, unable to continue                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GSK1363089, Intermittent 5 and 9 Dosing The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
GSK136308, Daily Dosing The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
Total Total of all reporting groups

Baseline Measures
   GSK1363089, Intermittent 5 and 9 Dosing   GSK136308, Daily Dosing   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   26   74 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.1  (12.68)   59.5  (15.35)   59.3  (13.57) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  27.1%      6  23.1%      19  25.7% 
Male      35  72.9%      20  76.9%      55  74.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      2   7.7%      2   2.7% 
Asian      2   4.2%      2   7.7%      4   5.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   4.2%      2   7.7%      4   5.4% 
White      42  87.5%      18  69.2%      60  81.1% 
More than one race      1   2.1%      0   0.0%      1   1.4% 
Unknown or Not Reported      1   2.1%      2   7.7%      3   4.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0   [ Time Frame: At every 8 Weeks upto 31 months ]

2.  Primary:   Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)   [ Time Frame: Up to 31 months ]

3.  Primary:   Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years) ]

4.  Primary:   Change From Baseline in Vital Signs-Pulse Rate   [ Time Frame: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years) ]

5.  Primary:   Change From Baseline in Temperature   [ Time Frame: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years) ]

6.  Primary:   Change From Baseline in Respiratory Rate (RR)   [ Time Frame: Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years) ]

7.  Primary:   Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded   [ Time Frame: From Day 1 and before 30-day follow- up (up to 2 years) ]

8.  Primary:   Number of Participants With Shift From Baseline in Serum Chemistry- Graded   [ Time Frame: From Day 1 to up to 30-day follow-up visit (up to 2 years) ]

9.  Primary:   Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters   [ Time Frame: From Day 1 and before 30-day follow- up (up to 2 years) ]

10.  Primary:   Number of Participants With Grade Shift for Urinalysis Parameters   [ Time Frame: From Day 1 and before 30-day follow- up (up to 2 years) ]

11.  Primary:   Number of Participants With Shift From Baseline by Grade for Hematology Parameters   [ Time Frame: Baseline (pre-dose) and before 30-day follow- up (up to 2 years) ]

12.  Primary:   Number of Participants Who Required Concomitant Medications   [ Time Frame: Baseline (pre-dose) and before 30-day follow- up (up to 2 years) ]

13.  Secondary:   Median Progression Free Survival (PFS) of GSK1363089   [ Time Frame: At every 8 Weeks upto 31 months ]

14.  Secondary:   Duration of Stable Disease of GSK1363089   [ Time Frame: At every 8 Weeks upto 31 months ]

15.  Secondary:   Disease Stabilization Rate of GSK 1363089   [ Time Frame: At every 8 Weeks upto 31 months ]

16.  Secondary:   Median Duration of Overall Survival (OS)of GSK1363089   [ Time Frame: At every 8 Weeks upto 31 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications of Results:
Jhawer M, Kindler HL, Wainberg Z, Ford J, Kunz P, Tang L, McCallum S, Kallender H, Shah MA Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancern (GC): Interim results of a multicenter phase II study J Clin Oncol 2009, 27 (15S), 4502.
Jhawer MP, Kindler HL, Wainberg ZA, Hecht JR, Kerr RO, Ford JM, Henderson C, Mueller T, Keer HN, Shah MA Preliminary activity of XL880, a dual MET/VEGFR2 inhibitor, in MET amplified poorly differentiated gastric cancer (PDGC): Interim results of a multicenter phase 2 study. J Clin Oncol, 2008, 26 (15S), Abstr. 4572

Other Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00725712     History of Changes
Obsolete Identifiers: NCT00415480
Other Study ID Numbers: MET111643
First Submitted: July 29, 2008
First Posted: July 30, 2008
Results First Submitted: July 23, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017