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A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Purpose

Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Placebo

S-1

Oxaliplatin

Paclitaxel

About this trial

This is an interventional treatment trial for Metastatic Gastric Adenocarcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a histopathologically or cytologically confirmed diagnosis of metastatic gastric or GEJ adenocarcinoma. Participants with esophageal cancer are not eligible.
Have not received any prior first-line systemic therapy for gastric or GEJ adenocarcinoma (prior adjuvant or neoadjuvant therapy is permitted). Participants whose disease has progressed after >24 weeks following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1).
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline.
Have adequate organ function.
Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.
Eligible participants of reproductive potential (both sexes) must agree to use contraception (hormonal or barrier methods) during the study period and at least 6 months after the last dose of study treatment or longer if required per local regulations.
Are willing to provide a blood sample for research purposes. Submission of a blood sample is mandatory for participation in this study unless restricted by local regulations or ethical review boards (ERBs); submission of a tumor tissue sample is optional.

Exclusion Criteria:

Participants with human epidermal growth factor receptor 2 (HER2)-positive status as determined per local standards. Participants with a negative test or having an indeterminate result due to any reason are eligible, provided these participants are not eligible for treatment directed against tumors which overexpress HER2.
Have radiation therapy within 14 days prior to randomization. Any lesion requiring palliative radiation or which has been previously irradiated cannot be considered for response assessment.
Have documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Have undergone major surgery within 28 days prior to randomization.
Are currently enrolled in, or discontinued study drug within the last 28 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants participating in surveys or observational studies are eligible to participate in this study.
Are pregnant or breast feeding. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to first dose of study treatment.
Have any prior malignancies.
Have any condition (eg, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggest that the participant is, in the investigator's opinion, not an appropriate candidate for the study.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-1/Oxaliplatin + Ramucirumab

S-1/Oxaliplatin + Placebo

Arm Description

(Part A) Ramucirumab intravenously (IV) on day 1 and day 8 along with S-1 by mouth (PO) on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

(Part A) Placebo IV on day 1 and day 8 along with S-1 PO on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.

Secondary Outcome Measures

Progression-free Survival to the Second Disease Progression (PFS 2)

Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy.

Overall Survival (OS)

Overall survival is defined as time from the date of randomization to the date of death from any cause. If the patient was alive at the cut-off for analysis (or lost to follow-up), OS data were censored for analysis on the last date the patient was known to be alive.

Percentage of Participants With Objective Response Rate (ORR)

The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR is defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.

Disease Control Rate (DCR)

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B.

Number of Participants With Anti-Ramucirumab Antibodies

Participant is considered as treatment emergent anti-drug antibody (TE ADA) positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.

Full Information

NCT ID

NCT02539225

First Posted

August 31, 2015

Last Updated

February 23, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02539225

Brief Title

A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of S-1 and Oxaliplatin With or Without Ramucirumab as First-line Therapy Followed by Paclitaxel With Ramucirumab as Second-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

October 5, 2015 (Actual)

Primary Completion Date

October 25, 2017 (Actual)

Study Completion Date

March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with or without ramucirumab as first line therapy in participants with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S-1/Oxaliplatin + Ramucirumab

Arm Type

Experimental

Arm Description

Arm Title

S-1/Oxaliplatin + Placebo

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

LY3009806, IMC-1121B, Cyramza

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

S-1

Intervention Description

Administered PO

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)

Secondary Outcome Measure Information:

Title

Progression-free Survival to the Second Disease Progression (PFS 2)

Description

Time Frame

Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months)

Title

Overall Survival (OS)

Description

Time Frame

Randomization to Death Due to Any Cause (Up to 31 Months)

Title

Percentage of Participants With Objective Response Rate (ORR)

Description

Time Frame

Randomization to Disease Progression (Up to 25 Months)

Title

Disease Control Rate (DCR)

Description

Time Frame

Randomization to Disease Progression (Up to 25 Months)

Title

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A

Description

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A.

Time Frame

Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose

Title

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B

Description

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B.

Time Frame

Cycle 1 Day 1 predose, Cycle 2 Day 1 predose

Title

Number of Participants With Anti-Ramucirumab Antibodies

Description

Time Frame

Baseline through 25 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a histopathologically or cytologically confirmed diagnosis of metastatic gastric or GEJ adenocarcinoma. Participants with esophageal cancer are not eligible. Have not received any prior first-line systemic therapy for gastric or GEJ adenocarcinoma (prior adjuvant or neoadjuvant therapy is permitted). Participants whose disease has progressed after >24 weeks following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible. Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1). Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline. Have adequate organ function. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator. Eligible participants of reproductive potential (both sexes) must agree to use contraception (hormonal or barrier methods) during the study period and at least 6 months after the last dose of study treatment or longer if required per local regulations. Are willing to provide a blood sample for research purposes. Submission of a blood sample is mandatory for participation in this study unless restricted by local regulations or ethical review boards (ERBs); submission of a tumor tissue sample is optional. Exclusion Criteria: Participants with human epidermal growth factor receptor 2 (HER2)-positive status as determined per local standards. Participants with a negative test or having an indeterminate result due to any reason are eligible, provided these participants are not eligible for treatment directed against tumors which overexpress HER2. Have radiation therapy within 14 days prior to randomization. Any lesion requiring palliative radiation or which has been previously irradiated cannot be considered for response assessment. Have documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. Have undergone major surgery within 28 days prior to randomization. Are currently enrolled in, or discontinued study drug within the last 28 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants participating in surveys or observational studies are eligible to participate in this study. Are pregnant or breast feeding. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to first dose of study treatment. Have any prior malignancies. Have any condition (eg, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggest that the participant is, in the investigator's opinion, not an appropriate candidate for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Akashi

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

City

Bunkyo-Ku

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

City

Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

City

Kochi

ZIP/Postal Code

781-8555

Country

Japan

Facility Name

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

City

Koto-ku

ZIP/Postal Code

135-8577

Country

Japan

Facility Name

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

Facility Name

City

Sagamihara

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

City

Sakai

ZIP/Postal Code

593-8304

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Shinjuku-Ku

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

City

Takatsuki

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

City

Toyonaka

ZIP/Postal Code

560-8565

Country

Japan

Facility Name

City

Utsunomiya

ZIP/Postal Code

320-0834

Country

Japan

Facility Name

City

Yokohama

ZIP/Postal Code

224-8503

Country

Japan

Facility Name

City

Yokohama

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Ulsan-si

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

31373648

Citation

Yoshikawa T, Muro K, Shitara K, Oh DY, Kang YK, Chung HC, Kudo T, Chin K, Kadowaki S, Hamamoto Y, Hironaka S, Yoshida K, Yen CJ, Omuro Y, Bai LY, Maeda K, Ozeki A, Yoshikawa R, Kitagawa Y. Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198243. doi: 10.1001/jamanetworkopen.2019.8243.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/1iuJn3anbEq6WK6y64aEY4

Description

A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

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A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

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