A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
RAINFALL
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)
3 other identifiers
interventional
645
20 countries
135
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Longer than P75 for phase_3
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedStudy Start
First participant enrolled
January 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2017
CompletedResults Posted
Study results publicly available
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2020
CompletedAugust 26, 2021
July 1, 2021
2 years
December 8, 2014
March 30, 2018
July 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)
Secondary Outcomes (12)
Overall Survival (OS)
Randomization to Death from Any Cause (Up To 30 Months)
Progression- Free Survival 2 (PFS2)
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)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Randomization to Disease Progression (Up To 26 Months)
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
Randomization to Disease Progression (Up To 26 Months)
Time to Progression (TTP)
Randomization to Disease Progression (Up To 24 Months)
- +7 more secondary outcomes
Study Arms (2)
Ramucirumab + Cisplatin + Capecitabine
EXPERIMENTAL8 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 + Cisplatin + Capecitabine
ACTIVE COMPARATORPlacebo 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.
Interventions
Administered IV
Administered orally
Administered IV
Administered IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (135)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
St Jude Medical Center
Fullerton, California, 92835, United States
SMO TRIO -Translational Research
Los Angeles, California, 90024, United States
UCLA Medical Center
Los Angeles, California, 90024, United States
Cancer Care Associates Medical Group
Redondo Beach, California, 90277, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Central Coast Medical Oncology Corporation
Santa Monica, California, 93454, United States
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06520-8020, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705, United States
Emory University
Atlanta, Georgia, 30322, United States
Illinois CancerCare
Peoria, Illinois, 61615, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
UT Southwestern Med Ctr
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
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Viedma, Río Negro Province, 8500, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Ciudad Autonoma Buenos Aires, 1093, Argentina
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La Rioja, 5300, Argentina
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Rosario, S2002KDS, Argentina
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Salta, 4400, Argentina
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Montreal, H2L 4M1, Canada
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Montreal, H4A 3J1, Canada
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Ottawa, K1H 8L6, Canada
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Toronto, M4N 3M5, Canada
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Toronto, M5B 1W8, Canada
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Toronto, M5G 1X5, Canada
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Toronto, M5G 2M9, Canada
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Vancouver, V5Z 4E6, Canada
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 775 20, Czechia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Aalborg, 9000, Denmark
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Aarhus C, 8000, Denmark
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Odense C, 5000, Denmark
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Helsinki, 00290 HUS, Finland
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Oulu, 90220, Finland
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Turku, SF-20520, Finland
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Avignon, 84918, France
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Clermont-Ferrand, 63003, France
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Lille, 59037, France
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Paris, 75015, France
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Saint-Etienne, 42055, France
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Saint-Herblain, 44805, France
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Villejuif, 94805, France
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Dresden, 01307, Germany
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Frankfurt am Main, 60488, Germany
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Hamburg, 20249, Germany
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Mannheim, 68167, Germany
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München, 81675, Germany
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Budapest, 1097, Hungary
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Debrecen, 4032, Hungary
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Szolnok, 5000, Hungary
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Haifa, 3525408, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 4941492, Israel
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Tel Aviv, 6423906, Israel
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Tel Litwinsky, 5265601, Israel
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Florence, 50134, Italy
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Milan, 20133, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Pisa, 56126, Italy
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Roma, 00168, Italy
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Torrette Di Ancona, 60020, Italy
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Udine, 33100, Italy
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Chiba, 260-8717, Japan
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Fukuoka, 811-1395, Japan
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Higashinari-Ku, 537-8511, Japan
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Kashiwa, 277 8577, Japan
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Kitaadachi-Gun, 362-0806, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Nagoya, 464-8681, Japan
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Osaka, 558-8558, Japan
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Suita-shi, 565-0871, Japan
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Sunto-Gun, 411-8777, Japan
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Utsunomiya, 320-0834, Japan
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Guadalajara, Jalisco, 44200, Mexico
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Mexico City, Mexico City, 03310, Mexico
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San Bernardino, Toluca, 50080, Mexico
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Juchitán, 70000, Mexico
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Mexico City, 14080, Mexico
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Mérida, 97138, Mexico
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México, 06760, Mexico
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Oaxaca City, 68000, Mexico
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Breda, 4819 EV, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Sittard - Geleen, 6162 BG, Netherlands
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Gdansk, 80-219, Poland
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Lodz, 93-513, Poland
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Poznan, 61-485, Poland
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Warsaw, 04-125, Poland
Ad-Vance Medical Research
Ponce, 00717, Puerto Rico
Hospital Espanol Auxilio Mutuo
San Juan, 00918, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921-3201, Puerto Rico
Hospital Municipal de San Juan
San Juan, 00935, Puerto Rico
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Arkhangelsk, 163045, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Elche, 03202, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Aberdeen, AB25 2ZN, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Merseyside, CH63 4JY, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (2)
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.
PMID: 34795131DERIVEDFuchs 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.
PMID: 30718072DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 10, 2014
Study Start
January 20, 2015
Primary Completion
January 17, 2017
Study Completion
August 14, 2020
Last Updated
August 26, 2021
Results First Posted
May 2, 2018
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.