Study Of Sunitinib In Combination With Cisplatin/Capecita... | NCT00555620

Label	Type	Description	Intervention Names
A	Experimental		Drug: capecitabine Drug: oxaliplatin Drug: sunitinib malate
B	Experimental		Drug: capecitabine Drug: cisplatin Drug: sunitinib malate

Name	Type	Description	Arm Group Labels	Other Names
capecitabine	Drug	Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.	A

Measure	Description	Time Frame
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)	Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.	Baseline up to Day 21

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)		Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)
Cmax of CAP		Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Goyang-si	Gyeonggi-do	410-769	South Korea
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
24091982	Derived	Lee KW, Park SR, Oh DY, Park YI, Khosravan R, Lin X, Lee SY, Roh EJ, Valota O, Lechuga MJ, Bang YJ. Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Invest New Drugs. 2013 Dec;31(6):1547-58. doi: 10.1007/s10637-013-0032-y. Epub 2013 Oct 4.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.

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 First-cycle Dose Limiting Toxicities (DLTs)

Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.

DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.

Posted

Number

participants

Baseline up to Day 21

ID	Title	Description
OG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG003	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG004	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG005	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010 OG0023 OG003

Secondary

Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)

Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Cmax of CAP

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units

Secondary

Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)

Posted

Mean

Standard Deviation

ng/mL

Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Cmin of CAP

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Cmin of 5'DFCR

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Cmin of 5'DFUR

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Cmin of 5-FU

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

ng/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Median

Full Range

hour (hr)

Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Tmax for CAP

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Median

Full Range

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Tmax for 5'DFCR

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Median

Full Range

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Tmax for 5'DFUR

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Median

Full Range

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Tmax for 5-FU

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Posted

Median

Full Range

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Units	Counts

Secondary

Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.

Posted

Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

t1/2 for CAP

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

t1/2 for 5'DFCR

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

t1/2 for 5'DFUR

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

t1/2 for 5-FU

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Posted

Mean

Standard Deviation

nanogram hours per milliliter (ng*hr/mL)

Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU

AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

AUClast for 5'DFCR

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

AUClast for 5'DFUR

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

AUClast for 5-FU

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Posted

Mean

Standard Deviation

ng*hr/mL

Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

ID	Title	Description
OG000	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Percentage of Participants With Objective Response

Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Day 21 of every even-numbered cycle up to 15 months

ID	Title	Description
OG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002

Secondary

Duration of Response (DR)

DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.

Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame

Posted

Median

Full Range

months

Baseline up to Month 15

ID	Title	Description
OG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Secondary

Progression-Free Survival (PFS)

PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Efficacy analysis subset of population of participants who had an event

Posted

Median

95% Confidence Interval

months

Baseline up to Month 15

ID	Title	Description
OG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
OG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
OG002	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG0030 affected23 at risk EG0040 affected3 at risk EG0050 affected22 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0022 affected15 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Duodenal perforation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Gastric perforation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Fatigue	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Pyrexia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Sudden death	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Pneumonia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Infectious peritonitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected6 at risk EG0014 affected7 at risk EG0029 affected15 at risk EG0038 affected23 at risk EG0041 affected3 at risk EG0052 affected22 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected6 at risk EG0013 affected7 at risk EG0020 affected15 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected6 at risk EG0016 affected7 at risk EG00215 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected6 at risk EG0016 affected7 at risk EG00210 affected15 at risk EG003
Hearing impaired	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Eyelid oedema	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Vision blurred	Eye disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected6 at risk EG0014 affected7 at risk EG0027 affected15 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected6 at risk EG0012 affected7 at risk EG0023 affected15 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0004 affected6 at risk EG0013 affected7 at risk EG0027 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected7 at risk EG0026 affected15 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0026 affected15 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0003 affected6 at risk EG0016 affected7 at risk EG00212 affected15 at risk EG003
Rectal tenesmus	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected6 at risk EG0013 affected7 at risk EG0028 affected15 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected7 at risk EG0025 affected15 at risk EG003
Asthenia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Chest discomfort	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Chest pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Chills	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0022 affected15 at risk EG003
Face oedema	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected7 at risk EG0020 affected15 at risk EG003
Fatigue	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0006 affected6 at risk EG0016 affected7 at risk EG0025 affected15 at risk EG003
Mucosal inflammation	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Oedema	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Oedema peripheral	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Pain	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Pyrexia	General disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0023 affected15 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Blood bilirubin increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Blood creatinine increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
International normalised ratio increased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Liver function test abnormal	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Platelet count	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Weight decreased	Investigations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0023 affected15 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0005 affected6 at risk EG0016 affected7 at risk EG00211 affected15 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0022 affected15 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Dizziness	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Headache	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0023 affected15 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0023 affected15 at risk EG003
Tremor	Nervous system disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected7 at risk EG0024 affected15 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0022 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected7 at risk EG0022 affected15 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0024 affected15 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0022 affected15 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Flushing	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0021 affected15 at risk EG003
Haematoma	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Hypertension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected7 at risk EG0021 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected7 at risk EG0020 affected15 at risk EG003
Pericoronitis	Infections and infestations	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected7 at risk EG0020 affected15 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (14.1)	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected7 at risk EG0020 affected15 at risk EG003

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D056831	Coordination Complexes
D009930	Organic Chemicals
D011758	Pyrroles
D001393	Azoles
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
BG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
BG002	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
BG003	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
BG004	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
BG005	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
BG006	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	1	6	6	6
EG001	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	2	7	7	7
EG002	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	8	15	15	15
EG003	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	8	23	23	23
EG004	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	0	3	3	3
EG005	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	5	22	22	22

ID	Term
D000069287	Capecitabine
D000077150	Oxaliplatin
D000077210	Sunitinib
D002945	Cisplatin