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A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer (RAINFALL)

Primary Purpose

Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Capecitabine

Cisplatin

Placebo

Fluorouracil

About this trial

This is an interventional treatment trial for Metastatic Gastric Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months 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). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
Have adequate organ function.
Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

Participants with adenocarcinoma of the esophagus are excluded.
Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
Have radiation therapy within 14 days prior to randomization.
Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.
Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding.
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
The participant has:
- 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. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Have known allergy or hypersensitivity to any components of study treatment.
Are pregnant or lactating.

Sites / Locations

Highlands Oncology Group
Comprehensive Blood and Cancer Center
St Jude Medical Center
SMO TRIO -Translational Research
UCLA Medical Center
Cancer Care Associates Medical Group
Coastal Integrative Cancer Care
Central Coast Medical Oncology Corporation
University of Colorado School of Medicine
Yale University School of Medicine
Holy Cross Hospital Inc.
Florida Cancer Specialists
Florida Cancer Specialists and Research Institute
Emory University
Illinois CancerCare
Dana Farber Cancer Institute
Weill Cornell Medical College
Memorial Sloan Kettering Cancer Center
Oncology Hematology Care Inc
Fox Chase Cancer Center
Allegheny General Hospital
SMO Sarah Cannon Research Inst.
Tennessee Oncology PLLC
UT Southwestern Med Ctr
Baylor College of Medicine
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Ad-Vance Medical Research
Hospital Espanol Auxilio Mutuo
VA Caribbean Healthcare System
Hospital Municipal de San Juan
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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

Ramucirumab + Cisplatin + Capecitabine

Placebo + Cisplatin + Capecitabine

Arm Description

8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.

Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.

Secondary Outcome Measures

Overall Survival (OS)

OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.

Progression- Free Survival 2 (PFS2)

PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

Time to Progression (TTP)

TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

Duration of Response (DoR)

Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.

Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale

Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.

Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.

Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.

Number of Participants With Anti-Ramucirumab Antibodies

Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab

Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab

PK: Minimum Concentration (Cmin) of Ramucirumab

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Full Information

NCT ID

NCT02314117

First Posted

December 8, 2014

Last Updated

July 29, 2021

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02314117

Brief Title

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

Acronym

RAINFALL

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

January 20, 2015 (Actual)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

August 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

645 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ramucirumab + Cisplatin + Capecitabine

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Cisplatin + Capecitabine

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)

Capecitabine

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Randomization to Death from Any Cause (Up To 30 Months)

Title

Progression- Free Survival 2 (PFS2)

Description

Time Frame

Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)

Title

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

Description

Time Frame

Randomization to Disease Progression (Up To 26 Months)

Title

Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

Description

Time Frame

Randomization to Disease Progression (Up To 26 Months)

Title

Time to Progression (TTP)

Description

Time Frame

Randomization to Disease Progression (Up To 24 Months)

Title

Duration of Response (DoR)

Description

Time Frame

Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)

Title

Description

Time Frame

Randomization, First worsening in QoL (Up To 26 Months)

Title

Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)

Description

Time Frame

Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)

Title

Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Description

Time Frame

Randomization to ECOG PS ≥2 (Up To 26 Months)

Title

Number of Participants With Anti-Ramucirumab Antibodies

Description

Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.

Time Frame

Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)

Title

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab

Description

Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab

Time Frame

Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI

Title

PK: Minimum Concentration (Cmin) of Ramucirumab

Description

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Time Frame

Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible. Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months 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). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline. Have adequate organ function. Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency). Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator. Exclusion Criteria: Participants with adenocarcinoma of the esophagus are excluded. Participants with human epidermal growth factor receptor 2 (HER2)-positive status. Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents. Have radiation therapy within 14 days prior to randomization. Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression. Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization. Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia. Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention. Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding. Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization. Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator. The participant has: 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. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. Have known allergy or hypersensitivity to any components of study treatment. Are pregnant or lactating.

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

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Comprehensive Blood and Cancer Center

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

St Jude Medical Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

SMO TRIO -Translational Research

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

Cancer Care Associates Medical Group

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Coastal Integrative Cancer Care

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Monica

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

University of Colorado School of Medicine

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8020

Country

United States

Facility Name

Holy Cross Hospital Inc.

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Florida Cancer Specialists and Research Institute

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Illinois CancerCare

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Oncology Hematology Care Inc

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

Facility Name

Allegheny General Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

SMO Sarah Cannon Research Inst.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

UT Southwestern Med Ctr

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

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

Viedma

State/Province

Rio Negro

ZIP/Postal Code

8500

Country

Argentina

Facility Name

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

1093

Country

Argentina

Facility Name

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Montreal

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Vancouver

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

City

Helsinki

ZIP/Postal Code

00290 HUS

Country

Finland

Facility Name

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

SF-20520

Country

Finland

Facility Name

City

Avignon Cedex 9

ZIP/Postal Code

84918

Country

France

Facility Name

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Frankfurt am Main

ZIP/Postal Code

60488

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

5265601

Country

Israel

Facility Name

City

Tel-Aviv Jaffa

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

City

Torrette Di Ancona

ZIP/Postal Code

60020

Country

Italy

Facility Name

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

City

Higashinari-Ku

ZIP/Postal Code

537-8511

Country

Japan

Facility Name

City

Kashiwa

ZIP/Postal Code

277 8577

Country

Japan

Facility Name

City

Kitaadachi-Gun

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

City

Kobe

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

Facility Name

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

City

Sunto-Gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

City

Utsunomiya

ZIP/Postal Code

320-0834

Country

Japan

Facility Name

City

Mexico City

State/Province

ZIP/Postal Code

03310

Country

Mexico

Facility Name

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44200

Country

Mexico

Facility Name

City

San Bernardino

State/Province

Toluca

ZIP/Postal Code

50080

Country

Mexico

Facility Name

City

Juchitan

ZIP/Postal Code

70000

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97138

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

06760

Country

Mexico

Facility Name

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

City

Sittard - Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-485

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

04-125

Country

Poland

Facility Name

Ad-Vance Medical Research

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

Hospital Espanol Auxilio Mutuo

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

VA Caribbean Healthcare System

City

San Juan

ZIP/Postal Code

00921-3201

Country

Puerto Rico

Facility Name

Hospital Municipal de San Juan

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Elche

ZIP/Postal Code

03202

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

City

Merseyside

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

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

34795131

Citation

Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

Results Reference

derived

PubMed Identifier

30718072

Citation

Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1. Erratum In: Lancet Oncol. 2019 May;20(5):e242.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/kPN4NxC5uCCu4eG6MMGeI?conditionId=B6nAiYh98OCsos8uoOISQ

Description

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

Learn more about this trial

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

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