Study of GSK1363089 in Metastatic Gastric Cancer | NCT00725712

Label	Type	Description	Intervention Names
5-days on/9-days off	Experimental	Dosing for first 5 days in every 14-day period.	Drug: GSK1363089 (formerly XL880)
daily dosing	Experimental	dosed every day	Drug: GSK1363089 (formerly XL880)

Name	Type	Description	Arm Group Labels	Other Names
GSK1363089 (formerly XL880)	Drug	c-MET tyrosine kinase inhibitor	5-days on/9-days off daily dosing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0	ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.	At every 8 Weeks upto 31 months
Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.	Up to 31 months
Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure	Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.

Secondary Outcomes

Measure	Description	Time Frame
Median Progression Free Survival (PFS) of GSK1363089	Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35294	United States
GSK Investigational Site

PubMed Identifier	Type	Citation
23516391	Background	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.
	Result	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.
	Result	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

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
MET111643	Annotated Case Report Form	View IPD

ID	Title	Description
FG000	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

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0

ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.

Evaluable population included participants from safety population who had received atleast 75% of protocol mandated doses at treatment period, had BL and post BL tumor assessment, with no extended lost to followup (17 wks or more) or who had received atleast 75% of protocol mandated doses at treatment period and discontinued study drug due to PD.

Posted

Number

participants

At every 8 Weeks upto 31 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00044 OG00125

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Primary

Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.

Posted

Number

participants

Up to 31 months

ID	Title	Description
OG000	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 200 mg) , 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.

Primary

Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure

Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmHg

Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Change From Baseline in Vital Signs-Pulse Rate

The pulse rate or heart rate (HR) for the participant's, were collected after the participant sat quietly for at least five minutes. Baseline evaluations were performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1. The HR was measured in beats per minute (bpm). The min and max values have been reported.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

beats per minute

Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Change From Baseline in Temperature

The body temperature for the participants was assessed. These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline is defined as the last non-missing record on or before first dose.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

degree celsius

Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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 200 mg) , 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.
OG001	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 and 9 dosing arm.

Primary

Change From Baseline in Respiratory Rate (RR)

The RR for the participant's, were collected after the participant sat quietly for at least five minutes. Baseline evaluations should be performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1 . The RR was measured in breaths per minute. Min and max post-baseline values are reported.

Safety population. Only those participants available at the specified time-points were analyzed.

Posted

Mean

Standard Deviation

breaths per minute

Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded

The data for serum chemistry parameters like albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), amylase, aspartate amino transferase (AST), calcium, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, blood urea nitrogen (BUN), chloride, free thyroxine, free triiodothyronine, lipase, phosphorous, potassium, sodium, total bilirubin, lactate dehydrogenase, total protein. The abnormal values have been reported wherein data for normal to low and normal to high has been reported.

Safety population. Only those participants available at the specified time points we re analyzed.

Posted

Number

participants

From Day 1 and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With Shift From Baseline in Serum Chemistry- Graded

The worst overall common terminology criteria for adverse events version 3.0 (CTCAE) grade (G) shift post baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading is done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases, aspartate aminotransferases, Albumin, alkaline phosphatase, calcium, sodium, potassium, glucose, amylase, amylase, bilirubin, creatinine, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. Worst Overall defined as worst post baseline out of normal range flag in the order of (high, low, normal) before 30 day follow up. Data for G3 and G4 is reported.

Safety population. Only those participants available at the specified time points were analyzed .

Posted

Count of Participants

Participants

From Day 1 to up to 30-day follow-up visit (up to 2 years)

ID	Title	Description
OG000	GSK1363089, Intermittent 5 & 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.
OG001	GSK136308, Daily Dosing

Primary

Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters

The hematology parameters worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. CTCAE grading for version 3.0 was used and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for basophils, eosinophils, erythrocytes, hematocrit, and monocytes were analyzed. Only the abnormal values were reported where normal to high and normal to low changes were reported. Worst Overall was defined as highest post baseline CTCAE grade before 30 day follow up.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Number

participants

From Day 1 and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With Grade Shift for Urinalysis Parameters

The urinalysis parameters by worst case overall CTCAE grade shift post Baseline for each parameter were mentioned as per the CTCAE grading for version 3.0 and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for abnormal values for bilirubin, ketones, nitrites, occult blood, pH, protein, specific gravity, and urobilinogen.

Safety population. Only those participants available at the specified timepoints were reported.

Posted

Number

participants

From Day 1 and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants With Shift From Baseline by Grade for Hematology Parameters

The worst overall grading by CTCAE version 3.0, was used to report the shift from baseline for hematology parameters namely hemoglobin, platelets and lymphocytes. The grades were namely G0, G1, G2, G3 and G4. The data for shifts from G2 to G3 and G0 to G4, mainly the shifts to higher grades G3 and G4 have been reported.

Safety population. Only those participants available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Baseline (pre-dose) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number of Participants Who Required Concomitant Medications

The number of participants who received concomitant medication during the study were reported. The data has been reported for the participants who have received subsequent chemotherapy, subsequent radiation therapy or other therapy.

Safety population.

Posted

Count of Participants

Participants

Baseline (pre-dose) and before 30-day follow- up (up to 2 years)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Median Progression Free Survival (PFS) of GSK1363089

Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.

Safety population

Posted

Median

95% Confidence Interval

months

At every 8 Weeks upto 31 months

ID	Title	Description
OG000	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.
OG001	GSK136308, Daily Dosing

Secondary

Duration of Stable Disease of GSK1363089

Duration of stable disease, was defined as the time between the date of first dose and death or disease progression, in participants whose best overall response was not progressive disease

Evaluable population. Only those participants available at the specified time-points were analyzed.

Posted

Median

95% Confidence Interval

months

At every 8 Weeks upto 31 months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Disease Stabilization Rate of GSK 1363089

It is defined as the number of participants achieving best overall response of confirmed CR or PR or stable disease (SD). It was assessed using RECIST criteria 1.0. The CR for target lesions was defined as disappearance of all TLs and the NTLs. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum LD since the treatment started.

Safety population

Posted

Number

95% Confidence Interval

percentage of participants

At every 8 Weeks upto 31 months

ID	Title	Description
OG000	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.
OG001	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

Secondary

Median Duration of Overall Survival (OS)of GSK1363089

Duration of OS is defined as (Date of Death [due to any cause]) minus Date of first dose. For the participants who were alive at the time of data cut-off, duration of overall survival was censored at the date of last contact. The upper value of the full range was censored observation.

Evaluable population

Posted

Median

Full Range

months

At every 8 Weeks upto 31 months

ID	Title	Description
OG000	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.
OG001	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0011 affected26 at risk
Cardiac arrest	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Photopsia	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Ascites	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0012 affected26 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Ileus	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0015 affected26 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0011 affected26 at risk
Upper gastrointestinal	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0014 affected26 at risk
Death	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Disease progression	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected26 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0011 affected26 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Alanine aminotransferase	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Aspartate aminotransferase	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Blood alkaline phosphatase	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Blood creatinine increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Blood urea increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Electrocardiogram change	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Platelet count decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Confusional state	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0010 affected26 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected26 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0010 affected26 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0011 affected26 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0010 affected26 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected48 at risk EG0019 affected26 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00017 affected48 at risk EG0016 affected26 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected48 at risk EG0015 affected26 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected48 at risk EG00112 affected26 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected48 at risk EG0018 affected26 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0015 affected26 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected48 at risk EG0011 affected26 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0013 affected26 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0013 affected26 at risk
Ascites	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Eructation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected26 at risk
Retching	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG00027 affected48 at risk EG00115 affected26 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected48 at risk EG0013 affected26 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected48 at risk EG0014 affected26 at risk
Mucosal inflammation	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected48 at risk EG0010 affected26 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected48 at risk EG0017 affected26 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected48 at risk EG0014 affected26 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected48 at risk EG0010 affected26 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected48 at risk EG0011 affected26 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected26 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG00015 affected48 at risk EG0012 affected26 at risk
Alanine aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG00011 affected48 at risk EG0012 affected26 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG00010 affected48 at risk EG0012 affected26 at risk
Weight decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0007 affected48 at risk EG0014 affected26 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0008 affected48 at risk EG0012 affected26 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0008 affected48 at risk EG0011 affected26 at risk
Lipase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected48 at risk EG0012 affected26 at risk
Blood creatinine increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0012 affected26 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected48 at risk EG0013 affected26 at risk
Dizziness	Nervous system disorders	Dizziness	Systematic Assessment	EG0004 affected48 at risk EG0016 affected26 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected48 at risk EG0010 affected26 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected48 at risk EG0012 affected26 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0012 affected26 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected48 at risk EG0014 affected26 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected48 at risk EG0011 affected26 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected48 at risk EG0011 affected26 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected48 at risk EG0013 affected26 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected48 at risk EG0012 affected26 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected48 at risk EG0015 affected26 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected48 at risk EG0014 affected26 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected48 at risk EG0013 affected26 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0012 affected26 at risk
Depression	Psychiatric disorders	Depression	Systematic Assessment	EG0002 affected48 at risk EG0013 affected26 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected48 at risk EG0011 affected26 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0011 affected26 at risk
Proteinuria	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected48 at risk EG0011 affected26 at risk
Hypothyroidism	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected48 at risk EG0012 affected26 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected48 at risk EG0010 affected26 at risk
Visual impairment	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected48 at risk EG0012 affected26 at risk

ID	Term
D009369	Neoplasms
D013274	Stomach Neoplasms
D000230	Adenocarcinoma

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 200 mg) , 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.	1	48	22	48	47	48
EG001	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 and 9 dosing arm.	0	26	16	26	23	26