A Study of Ramucirumab Combination Therapy in Japanese Pa... | NCT02359058

NCT02359058

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I4T-JE-JVCX	Other Identifier	Eli Lilly

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ramucirumab + Capecitabine + Cisplatin	Other	Ramucirumab (8 milligram per kilogram (mg/kg) given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.	Drug: Ramucirumab Drug: Capecitabine Drug: Cisplatin
Ramucirumab + S-1 + Cisplatin	Other	Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.	Drug: Ramucirumab Drug: Cisplatin Drug: S-1
Ramucirumab + S-1 + Oxaliplatin	Other	Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Drug: Ramucirumab Drug: S-1 Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
Ramucirumab	Drug	Administered IV	Ramucirumab + Capecitabine + Cisplatin Ramucirumab + S-1 + Cisplatin Ramucirumab + S-1 + Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Maximum Serum Concentration (Cmax) of Ramucirumab.	Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after >6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
The participant has adequate organ function.
Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version [v]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer.
Female participants of childbearing potential must have a negative serum or urinary pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
Uncontrolled arterial hypertension, despite standard medical management.
A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
Radiation therapy within 14 days prior to enrollment.
Received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
A serious illness or medical condition(s).
Pregnant or breastfeeding.
Dysphagia for oral medication.
Known allergy or hypersensitivity to any study treatment.
Human epidermal growth factor receptor (HER) 2 status of positive.
Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.		Aichi		464-8681

Arm/Group Information

ID	Title	Description
FG000	Ramucirumab + Capecitabine + Cisplatin	Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
FG001	Ramucirumab + S-1 + Cisplatin	Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
FG002	Ramucirumab + S-1 + Oxaliplatin	Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Ramucirumab + Capecitabine + Cisplatin	Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

All enrolled participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)

ID	Title	Description
OG000	Ramucirumab + Capecitabine + Cisplatin	Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ramucirumab + Capecitabine + Cisplatin	Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

ID	Term
D000096662	Ramucirumab
D000069287	Capecitabine
D002945	Cisplatin
C079198	S 1 (combination)
D000077150	Oxaliplatin