Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
4 other identifiers
interventional
355
30 countries
161
Brief Summary
The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Aug 2009
Typical duration for phase_3 gastric-cancer
161 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
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 25, 2019
September 1, 2019
2.9 years
June 8, 2009
May 21, 2014
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
Randomization up to 28 months post-randomization
Secondary Outcomes (8)
Progression-Free Survival (PFS)
Randomization up to 17 months
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
Week 12 post-randomization
Percentage of Participants With Objective Response (Objective Response Rate [ORR])
Randomization up to 17 months post-randomization
Duration of Response (DOR)
Randomization up to 17 months post-randomization
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
- +3 more secondary outcomes
Study Arms (2)
ramucirumab
EXPERIMENTALParticipants receive ramucirumab, administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), and best supportive care (BSC) as determined appropriate by the investigator(s). Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Placebo
PLACEBO COMPARATORParticipants receive injection for intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel will be blinded as to assignment to active therapy versus placebo, the volume of placebo to be administered will be calculated as if it were active product with a dose of 8 mg/kg. Treatment will continue until there is evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Interventions
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma
- Metastatic disease or locally recurrent, unresectable disease with measurable lymph node metastases
- Measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion \[≥ 2 centimeter (cm) with conventional techniques or ≥ 1 cm by spiral computed tomography (CT)\], as defined by Response using Response Evaluation Criteria in Solid Tumors (RECIST).
- Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST
- Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
- Disease is not amenable to potentially curative resection
- Participant is ≥ 18 years of age
- Participant has a life expectancy of ≥ 12 weeks
- Participant resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1
- The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 milligrams/deciliter (mg/dL) \[25.65 micromole/liter (µmol/L)\], and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) \[or 5.0 x the ULN in the setting of liver metastases\]
- The participant has adequate renal function as defined by a serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 40 milliliters/minute (mL/min) (that is, if serum creatinine is \> 1.5 x the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
- The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (\[UA\]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate \< 1000 milligrams (mg) of protein in 24 hours to allow participation in the study)
- The participant has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000 microliters (µL), hemoglobin ≥ 9 grams/deciliter (g/dL) \[5.58 millimoles/liter (mmol/L)\], and platelets ≥ 100,000/µL
- The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Participant on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible
- +4 more criteria
You may not qualify if:
- Documented and/or symptomatic brain or leptomeningeal metastases
- Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization
- Experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator
- Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements
- Uncontrolled or poorly-controlled hypertension despite standard medical management
- Participant has a serious or nonhealing wound, ulcer, or bone fracture
- Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization
- Received any investigational therapy within 30 days prior to randomization
- Undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
- Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or VEGF receptor 2 (R-2) activity (including bevacizumab), or any antiangiogenic agent
- Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use \[maximum dose 325 milligram/day (mg/day)\] is permitted
- Participant has elective or planned major surgery to be performed during the course of the clinical trial
- Participant has a known allergy to any of the treatment components
- Pregnant or lactating
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (161)
ImClone Investigational Site
Bakersfield, California, 93309, United States
ImClone Investigational Site
La Jolla, California, 92093, United States
ImClone Investigational Site
Redlands, California, 92374, United States
ImClone Investigational Site
Chicago, Illinois, 60612, United States
ImClone Investigational Site
New Orleans, Louisiana, 70112, United States
ImClone Investigational Site
Boston, Massachusetts, 02115, United States
ImClone Investigational Site
Omaha, Nebraska, 68114, United States
ImClone Investigational Site
New York, New York, 10003, United States
ImClone Investigational Site
West Reading, Pennsylvania, 19611, United States
ImClone Investigational Site
Providence, Rhode Island, 02903, United States
ImClone Investigational Site
Charleston, South Carolina, 29425, United States
ImClone Investigational Site
Knoxville, Tennessee, 37920, United States
ImClone Investigational Site
Memphis, Tennessee, 38119, United States
ImClone Investigational Site
Houston, Texas, 77030, United States
ImClone Investigational Site
Buenos Aires, 1425, Argentina
ImClone Investigational Site
Buenos Aires, C1437JCP, Argentina
ImClone Investigational Site
Capital Federal, 1264, Argentina
ImClone Investigational Site
Ciudada Autonoma, C1199ABD, Argentina
ImClone Investigational Site
Córdoba, 5000, Argentina
ImClone Investigational Site
Rosario, S2002KDS, Argentina
ImClone Investigational Site
Wodonga, New South Wales, 3690, Australia
ImClone Investigational Site
Hobart, Tasmania, 7000, Australia
ImClone Investigational Site
East Melbourne, Victoria, 3002, Australia
ImClone Investigational Site
Perth, Western Australia, 6000, Australia
ImClone Investigational Site
Bedford Park, 5042, Australia
ImClone Investigational Site
St Leonards, NSW 2065, Australia
ImClone Investigational Site
Woodville, 5011, Australia
ImClone Investigational Site
Sarajevo, 71000, Bosnia and Herzegovina
ImClone Investigational Site
Barretos, 14784-400, Brazil
ImClone Investigational Site
Belo Horizonte, 30110-090, Brazil
ImClone Investigational Site
Belo Horizonte, 30150-281, Brazil
ImClone Investigational Site
Brasília, 70390-150, Brazil
ImClone Investigational Site
Curitiba, 80730-130, Brazil
ImClone Investigational Site
Curitiba, 81520-060, Brazil
ImClone Investigational Site
Florianópolis, 88034-000, Brazil
ImClone Investigational Site
Ijuí, 98700-000, Brazil
ImClone Investigational Site
Lajeados, 95900-000, Brazil
ImClone Investigational Site
Londrina, 86050-190, Brazil
ImClone Investigational Site
Passo Fundo, 99010-260, Brazil
ImClone Investigational Site
Porto Alegre, 90035-903, Brazil
ImClone Investigational Site
Porto Alegre, 90610-970, Brazil
ImClone Investigational Site
Porto Alegre, 90840-440, Brazil
ImClone Investigational Site
São Paulo, 01406-100, Brazil
ImClone Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
ImClone Investigational Site
Montreal, Quebec, H2L 4M1, Canada
ImClone Investigational Site
Sherbrooke, Quebec, J1G 2E8, Canada
ImClone Investigational Site
Concepción, 407-0038, Chile
ImClone Investigational Site
La Serena, Chile
ImClone Investigational Site
Santiago, 6570917, Chile
ImClone Investigational Site
Montería, Colombia
ImClone Investigational Site
Osijek, 31 100, Croatia
ImClone Investigational Site
Pula, 52100, Croatia
ImClone Investigational Site
Slavonski Brod, 35 000, Croatia
ImClone Investigational Site
Zagreb, 10 000, Croatia
ImClone Investigational Site
Brno, 656 53, Czechia
ImClone Investigational Site
Hradec Králové, 500 05, Czechia
ImClone Investigational Site
Liberec, 460 63, Czechia
ImClone Investigational Site
Nová Ves pod Pleší, 262 04, Czechia
ImClone Investigational Site
Olomouc, 775 20, Czechia
ImClone Investigational Site
Pardubice, 532 03, Czechia
ImClone Investigational Site
Prague, 100 34, Czechia
ImClone Investigational Site
Prague, 128 08, Czechia
ImClone Investigational Site
Prague, 180 81, Czechia
ImClone Investigational Site
Příbram, 261 95, Czechia
ImClone Investigational Site
Alexandria, 21131, Egypt
ImClone Investigational Site
Cairo, 11796, Egypt
ImClone Investigational Site
Guatemala City, 01010, Guatemala
ImClone Investigational Site
Guatemala City, Guatemala
ImClone Investigational Site
Hyderabad, ANDH PRAD, 500004, India
ImClone Investigational Site
Hyderabad, ANDH PRAD, 500033, India
ImClone Investigational Site
Bangalore, Karna, 560 025, India
ImClone Investigational Site
Bangalore, Karna, 560054, India
ImClone Investigational Site
Kochi, Kerala, 682304, India
ImClone Investigational Site
Thiruvananthapuram, Kerala, 695011, India
ImClone Investigational Site
Trivandrum, Kerala, 695011, India
ImClone Investigational Site
Chennai, Kilpauk, 600 010, India
ImClone Investigational Site
Bhopal, MADH PRAD, 462001, India
ImClone Investigational Site
Indore, MADH PRAD, 452008, India
ImClone Investigational Site
Mumbai, Mahara, 400016, India
ImClone Investigational Site
Nashik, Mahara, 422 004, India
ImClone Investigational Site
Pune, Mahara, 411001, India
ImClone Investigational Site
New Delhi, National Capital Territory of Delhi, 110085, India
ImClone Investigational Site
Chennai, Tamil Nadu, 600010, India
ImClone Investigational Site
Chennai, Tamil Nadu, 600035, India
ImClone Investigational Site
Kolkata, West Bengal, 700053, India
ImClone Investigational Site
Kolkata, West Bengal, 700054, India
ImClone Investigational Site
Bangalore, 560 029, India
ImClone Investigational Site
Chennai, 600010, India
ImClone Investigational Site
Hyderabad, 500 033, India
ImClone Investigational Site
Hyderabad, 500004, India
ImClone Investigational Site
Kolkata, 700053, India
ImClone Investigational Site
Mumbai, 400 012, India
ImClone Investigational Site
Mumbai, 400016, India
ImClone Investigational Site
Pune, 411001, India
ImClone Investigational Site
West Bengal, 700054, India
ImClone Investigational Site
Jakarta, 10440, Indonesia
ImClone Investigational Site
Jakarta, 11420, Indonesia
ImClone Investigational Site
Jakarta, 14450, Indonesia
ImClone Investigational Site
Sumatera Utara, 20136, Indonesia
ImClone Investigational Site
West Java, 40161, Indonesia
ImClone Investigational Site
Aviano, 33081, Italy
ImClone Investigational Site
Bologna, 40138, Italy
ImClone Investigational Site
Brescia, 25123, Italy
ImClone Investigational Site
Cremona, 26100, Italy
ImClone Investigational Site
Lido di Camaiore, 55043, Italy
ImClone Investigational Site
Lucca, 55043, Italy
ImClone Investigational Site
Meldola, 47014, Italy
ImClone Investigational Site
Mirano, 30035, Italy
ImClone Investigational Site
Noale, 30033, Italy
ImClone Investigational Site
Potenza, 85100, Italy
ImClone Investigational Site
Rimini, 47900, Italy
ImClone Investigational Site
Udine, 33100, Italy
ImClone Investigational Site
Beirut, Lebanon
ImClone Investigational Site
Floriana, 1941, Malta
ImClone Investigational Site
Floriana, FRN 1941, Malta
ImClone Investigational Site
Aguascelientes, 20217, Mexico
ImClone Investigational Site
Christchurch, 8011, New Zealand
ImClone Investigational Site
Cebu City, 6000, Philippines
ImClone Investigational Site
Pasig, 1604, Philippines
ImClone Investigational Site
Gdansk, 80-219, Poland
ImClone Investigational Site
Krakow, 31-108, Poland
ImClone Investigational Site
Olsztyn, 10-513, Poland
ImClone Investigational Site
Baia Mare, 430031, Romania
ImClone Investigational Site
Cluj-Napoca, 400015, Romania
ImClone Investigational Site
Cluj-Napoca, 400058, Romania
ImClone Investigational Site
Suceava, 720237, Romania
ImClone Investigational Site
Chelyabinsk, 454087, Russia
ImClone Investigational Site
Kursk, 305035, Russia
ImClone Investigational Site
Moscow, 115478, Russia
ImClone Investigational Site
Moscow, 125367, Russia
ImClone Investigational Site
Pyatigorsk, 357524, Russia
ImClone Investigational Site
Saint Petersburg, 195067, Russia
ImClone Investigational Site
Saint Petersburg, 197022, Russia
ImClone Investigational Site
Saint Petersburg, 197758, Russia
ImClone Investigational Site
Cape Town, 7925, South Africa
ImClone Investigational Site
Seoul, 120-752, South Korea
ImClone Investigational Site
Seoul, 135-720, South Korea
ImClone Investigational Site
Seoul, 136-705, South Korea
ImClone Investigational Site
Seoul, 137-701, South Korea
ImClone Investigational Site
Alcorcón, 28922, Spain
ImClone Investigational Site
Barcelona, 08035, Spain
ImClone Investigational Site
Barcelona, 08036, Spain
ImClone Investigational Site
Elche, 03203, Spain
ImClone Investigational Site
Madrid, 28034, Spain
ImClone Investigational Site
Santander, 39008, Spain
ImClone Investigational Site
Seville, 41021, Spain
ImClone Investigational Site
Kaohsiung City, 807, Taiwan
ImClone Investigational Site
Taichung County, 433, Taiwan
ImClone Investigational Site
Taipei, 111, Taiwan
ImClone Investigational Site
Taipei, 116, Taiwan
ImClone Investigational Site
Bangkok, 10400, Thailand
ImClone Investigational Site
Chiang Mai, 50002, Thailand
ImClone Investigational Site
Rajathevee District, 10400, Thailand
ImClone Investigational Site
Adana, 01330, Turkey (Türkiye)
ImClone Investigational Site
Gaziantep, 27310, Turkey (Türkiye)
ImClone Investigational Site
Istanbul, 34718, Turkey (Türkiye)
ImClone Investigational Site
Izmir, 35100, Turkey (Türkiye)
ImClone Investigational Site
Bebington, Wirral, L83 4JY, United Kingdom
ImClone Investigational Site
London, SE1 7EH, United Kingdom
ImClone Investigational Site
Sutton, SM2 5PT, United Kingdom
ImClone Investigational Site
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (3)
Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.
PMID: 30557792DERIVEDTabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.
PMID: 28716815DERIVEDFuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
PMID: 24094768DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
August 1, 2009
Primary Completion
July 1, 2012
Study Completion
December 1, 2015
Last Updated
September 25, 2019
Results First Posted
October 16, 2014
Record last verified: 2019-09
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.