Trial · NCT02359058

A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer

NCT02359058, Phase 1, Completed, Eli Lilly and Company; results first posted 2017-12-04

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer. Trials, record NCT02359058. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02359058

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
NCT number: NCT02359058
Status: Completed
Phases: Phase 1
Enrollment: 18 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Stomach Neoplasms
Interventions: Ramucirumab, Capecitabine, Cisplatin, S-1, Oxaliplatin
First posted: 2015-02-09
Last updated: 2018-01-24
Results first posted: 2017-12-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)	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.
Secondary	Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion	Maximum Serum Concentration (Cmax) of Ramucirumab.
Secondary	Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab	Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose	Minimum Serum Concentration (Cmin) of Ramucirumab.
Secondary	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)	First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)	Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.
Secondary	Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)	First dose to study completion plus 30-day safety follow-up (Up To 22 Months)	Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)	All enrolled participants who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion	All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.	microgram per milliliter (μg/mL)	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab	Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose	All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.	μg/mL	GEOMETRIC_MEAN
SECONDARY	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)	First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)	All enrolled participants who received at least one dose of study drug and with measurable disease.	Percentage of participants	NUMBER
SECONDARY	Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)	First dose to study completion plus 30-day safety follow-up (Up To 22 Months)	All enrolled participants who received at least one dose of the study drug and had evaluable immunogenicity data.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group58

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Ramucirumab + Capecitabine + Cisplatin		1		Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Ramucirumab + S-1 + Cisplatin		2		Participants
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Ramucirumab + S-1 + Oxaliplatin		2		Participants
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + Capecitabine + Cisplatin	Day 1	149	Geometric Coefficient of Variation 21	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + S-1 + Cisplatin	Day 1	139	Geometric Coefficient of Variation 23	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + S-1 + Oxaliplatin	Day 1	137	Geometric Coefficient of Variation 20	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + Capecitabine + Cisplatin	Day 8	229	Geometric Coefficient of Variation 24	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + S-1 + Cisplatin	Day 8	200	Geometric Coefficient of Variation 21	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + S-1 + Oxaliplatin	Day 8	211	Geometric Coefficient of Variation 11	microgram per milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab	Ramucirumab + Capecitabine + Cisplatin	Day 43	205	Geometric Coefficient of Variation 24	microgram per milliliter (μg/mL)

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ramucirumab + Capecitabine + Cisplatin	6
Overall Study	STARTED	Ramucirumab + S-1 + Cisplatin	6
Overall Study	STARTED	Ramucirumab + S-1 + Oxaliplatin	6
Overall Study	Received at Least 1 Dose of Study Drug	Ramucirumab + Capecitabine + Cisplatin	6
Overall Study	Received at Least 1 Dose of Study Drug	Ramucirumab + S-1 + Cisplatin	6
Overall Study	Received at Least 1 Dose of Study Drug	Ramucirumab + S-1 + Oxaliplatin	6
Overall Study	COMPLETED	Ramucirumab + Capecitabine + Cisplatin	6
Overall Study	COMPLETED	Ramucirumab + S-1 + Cisplatin	6
Overall Study	COMPLETED	Ramucirumab + S-1 + Oxaliplatin	6
Overall Study	NOT COMPLETED	Ramucirumab + Capecitabine + Cisplatin	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events252

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Ramucirumab + Capecitabine + Cisplatin	2	6	3
other	Anaemia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Cisplatin	3	6	3
other	Anaemia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Oxaliplatin	1	6	1
other	Leukopenia	Blood and lymphatic system disorders	Ramucirumab + Capecitabine + Cisplatin	1	6	2
other	Leukopenia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Cisplatin	0	6	0
other	Leukopenia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Oxaliplatin	0	6	0
other	Neutropenia	Blood and lymphatic system disorders	Ramucirumab + Capecitabine + Cisplatin	4	6	8
other	Neutropenia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Cisplatin	1	6	1
other	Neutropenia	Blood and lymphatic system disorders	Ramucirumab + S-1 + Oxaliplatin	2	6	20
other	Thrombocytopenia	Blood and lymphatic system disorders	Ramucirumab + Capecitabine + Cisplatin	0	6	0

1 to 10 of 252Source ClinicalTrials.gov

See all 252 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ramucirumab + Capecitabine + Cisplatin
Total, all-cause mortality	Ramucirumab + S-1 + Cisplatin
Total, all-cause mortality	Ramucirumab + S-1 + Oxaliplatin
Total, other adverse events	Ramucirumab + Capecitabine + Cisplatin	6	6
Total, other adverse events	Ramucirumab + S-1 + Cisplatin	6	6
Total, other adverse events	Ramucirumab + S-1 + Oxaliplatin	5	6
Total, serious adverse events	Ramucirumab + Capecitabine + Cisplatin	1	6
Total, serious adverse events	Ramucirumab + S-1 + Cisplatin	2	6
Total, serious adverse events	Ramucirumab + S-1 + Oxaliplatin	2	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02359058

GET https://conductscience.org/api/trials/v1/NCT02359058/results?page=2

API reference For AI assistants