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AzTrials

Gastric CancerPhase 3NCT00917384

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

A Phase 3 study testing ramucirumab in people with Gastric Cancer and Adenocarcinoma, run by Eli Lilly and Company at 161 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Adenocarcinoma
What is being tested?
ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
355 participants
Where
161 sitesin 30 countries
Study dates
Aug 2009to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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
  • If the participant has received prior anthracycline therapy as part of his or her first-line regimen, the participant is able to engage in ordinary physical activity without significant fatigue or dyspnea
  • Because the teratogenicity of IMC-1121B is not known, the participant, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
  • Female participant of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization
  • Able to provide informed written consent and is amenable to compliance with protocol schedules and testing

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Known to be positive for infection with the human immunodeficiency virus
  • Known alcohol or drug dependency
  • Participant has a concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years

Trial locations and contacts

161 sites in 30 countries.

161 sites in 30 countries

India27 sites

  • ImClone Investigational Site

    Bangalore, Karna, 560 025

  • ImClone Investigational Site

    Bangalore, Karna, 560054

  • ImClone Investigational Site

    Bangalore, 560 029

  • ImClone Investigational Site

    Bhopal, MADH PRAD, 462001

  • ImClone Investigational Site

    Chennai, Kilpauk, 600 010

  • ImClone Investigational Site

    Chennai, Tamil Nadu, 600010

  • ImClone Investigational Site

    Chennai, Tamil Nadu, 600035

  • ImClone Investigational Site

    Chennai, 600010

  • ImClone Investigational Site

    Hyderabad, ANDH PRAD, 500004

  • ImClone Investigational Site

    Hyderabad, ANDH PRAD, 500033

  • ImClone Investigational Site

    Hyderabad, 500 033

  • ImClone Investigational Site

    Hyderabad, 500004

  • ImClone Investigational Site

    Indore, MADH PRAD, 452008

  • ImClone Investigational Site

    Kochi, Kerala, 682304

  • ImClone Investigational Site

    Kolkata, West Bengal, 700053

  • ImClone Investigational Site

    Kolkata, West Bengal, 700054

  • ImClone Investigational Site

    Kolkata, 700053

  • ImClone Investigational Site

    Mumbai, Mahara, 400016

  • ImClone Investigational Site

    Mumbai, 400 012

  • ImClone Investigational Site

    Mumbai, 400016

  • ImClone Investigational Site

    Nashik, Mahara, 422 004

  • ImClone Investigational Site

    New Delhi, National Capital Territory of Delhi, 110085

  • ImClone Investigational Site

    Pune, Mahara, 411001

  • ImClone Investigational Site

    Pune, 411001

  • ImClone Investigational Site

    Thiruvananthapuram, Kerala, 695011

  • ImClone Investigational Site

    Trivandrum, Kerala, 695011

  • ImClone Investigational Site

    West Bengal, 700054

Other trials in India

Brazil15 sites

  • ImClone Investigational Site

    Barretos, 14784-400

  • ImClone Investigational Site

    Belo Horizonte, 30110-090

  • ImClone Investigational Site

    Belo Horizonte, 30150-281

  • ImClone Investigational Site

    Brasília, 70390-150

  • ImClone Investigational Site

    Curitiba, 80730-130

  • ImClone Investigational Site

    Curitiba, 81520-060

  • ImClone Investigational Site

    Florianópolis, 88034-000

  • ImClone Investigational Site

    Ijuí, 98700-000

  • ImClone Investigational Site

    Lajeados, 95900-000

  • ImClone Investigational Site

    Londrina, 86050-190

  • ImClone Investigational Site

    Passo Fundo, 99010-260

  • ImClone Investigational Site

    Porto Alegre, 90035-903

  • ImClone Investigational Site

    Porto Alegre, 90610-970

  • ImClone Investigational Site

    Porto Alegre, 90840-440

  • ImClone Investigational Site

    São Paulo, 01406-100

Other trials in Brazil

United States14 sites

  • ImClone Investigational Site

    Bakersfield, California, 93309

  • ImClone Investigational Site

    Boston, Massachusetts, 02115

  • ImClone Investigational Site

    Charleston, South Carolina, 29425

  • ImClone Investigational Site

    Chicago, Illinois, 60612

  • ImClone Investigational Site

    Houston, Texas, 77030

  • ImClone Investigational Site

    Knoxville, Tennessee, 37920

  • ImClone Investigational Site

    La Jolla, California, 92093

  • ImClone Investigational Site

    Memphis, Tennessee, 38119

  • ImClone Investigational Site

    New Orleans, Louisiana, 70112

  • ImClone Investigational Site

    New York, New York, 10003

  • ImClone Investigational Site

    Omaha, Nebraska, 68114

  • ImClone Investigational Site

    Providence, Rhode Island, 02903

  • ImClone Investigational Site

    Redlands, California, 92374

  • ImClone Investigational Site

    West Reading, Pennsylvania, 19611

Other trials in United States

Italy12 sites

  • ImClone Investigational Site

    Aviano, 33081

  • ImClone Investigational Site

    Bologna, 40138

  • ImClone Investigational Site

    Brescia, 25123

  • ImClone Investigational Site

    Cremona, 26100

  • ImClone Investigational Site

    Lido di Camaiore, 55043

  • ImClone Investigational Site

    Lucca, 55043

  • ImClone Investigational Site

    Meldola, 47014

  • ImClone Investigational Site

    Mirano, 30035

  • ImClone Investigational Site

    Noale, 30033

  • ImClone Investigational Site

    Potenza, 85100

  • ImClone Investigational Site

    Rimini, 47900

  • ImClone Investigational Site

    Udine, 33100

Other trials in Italy

Czechia10 sites

  • ImClone Investigational Site

    Brno, 656 53

  • ImClone Investigational Site

    Hradec Králové, 500 05

  • ImClone Investigational Site

    Liberec, 460 63

  • ImClone Investigational Site

    Nová Ves pod Pleší, 262 04

  • ImClone Investigational Site

    Olomouc, 775 20

  • ImClone Investigational Site

    Pardubice, 532 03

  • ImClone Investigational Site

    Prague, 100 34

  • ImClone Investigational Site

    Prague, 128 08

  • ImClone Investigational Site

    Prague, 180 81

  • ImClone Investigational Site

    Příbram, 261 95

Other trials in Czechia

Russia8 sites

  • ImClone Investigational Site

    Chelyabinsk, 454087

  • ImClone Investigational Site

    Kursk, 305035

  • ImClone Investigational Site

    Moscow, 115478

  • ImClone Investigational Site

    Moscow, 125367

  • ImClone Investigational Site

    Pyatigorsk, 357524

  • ImClone Investigational Site

    Saint Petersburg, 195067

  • ImClone Investigational Site

    Saint Petersburg, 197022

  • ImClone Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Australia7 sites

  • ImClone Investigational Site

    Bedford Park, 5042

  • ImClone Investigational Site

    East Melbourne, Victoria, 3002

  • ImClone Investigational Site

    Hobart, Tasmania, 7000

  • ImClone Investigational Site

    Perth, Western Australia, 6000

  • ImClone Investigational Site

    St Leonards, NSW 2065

  • ImClone Investigational Site

    Wodonga, New South Wales, 3690

  • ImClone Investigational Site

    Woodville, 5011

Other trials in Australia

Spain7 sites

  • ImClone Investigational Site

    Alcorcón, 28922

  • ImClone Investigational Site

    Barcelona, 08035

  • ImClone Investigational Site

    Barcelona, 08036

  • ImClone Investigational Site

    Elche, 03203

  • ImClone Investigational Site

    Madrid, 28034

  • ImClone Investigational Site

    Santander, 39008

  • ImClone Investigational Site

    Seville, 41021

Other trials in Spain

Argentina6 sites

  • ImClone Investigational Site

    Buenos Aires, 1425

  • ImClone Investigational Site

    Buenos Aires, C1437JCP

  • ImClone Investigational Site

    Capital Federal, 1264

  • ImClone Investigational Site

    Ciudada Autonoma, C1199ABD

  • ImClone Investigational Site

    Córdoba, 5000

  • ImClone Investigational Site

    Rosario, S2002KDS

Other trials in Argentina

Indonesia5 sites

  • ImClone Investigational Site

    Jakarta, 10440

  • ImClone Investigational Site

    Jakarta, 11420

  • ImClone Investigational Site

    Jakarta, 14450

  • ImClone Investigational Site

    Sumatera Utara, 20136

  • ImClone Investigational Site

    West Java, 40161

Other trials in Indonesia

Croatia4 sites

  • ImClone Investigational Site

    Osijek, 31 100

  • ImClone Investigational Site

    Pula, 52100

  • ImClone Investigational Site

    Slavonski Brod, 35 000

  • ImClone Investigational Site

    Zagreb, 10 000

Other trials in Croatia

Romania4 sites

  • ImClone Investigational Site

    Baia Mare, 430031

  • ImClone Investigational Site

    Cluj-Napoca, 400015

  • ImClone Investigational Site

    Cluj-Napoca, 400058

  • ImClone Investigational Site

    Suceava, 720237

Other trials in Romania

South Korea4 sites

  • ImClone Investigational Site

    Seoul, 120-752

  • ImClone Investigational Site

    Seoul, 135-720

  • ImClone Investigational Site

    Seoul, 136-705

  • ImClone Investigational Site

    Seoul, 137-701

Other trials in South Korea

Taiwan4 sites

  • ImClone Investigational Site

    Kaohsiung City, 807

  • ImClone Investigational Site

    Taichung County, 433

  • ImClone Investigational Site

    Taipei, 111

  • ImClone Investigational Site

    Taipei, 116

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • ImClone Investigational Site

    Adana, 01330

  • ImClone Investigational Site

    Gaziantep, 27310

  • ImClone Investigational Site

    Istanbul, 34718

  • ImClone Investigational Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

United Kingdom4 sites

  • ImClone Investigational Site

    Bebington, Wirral, L83 4JY

  • ImClone Investigational Site

    London, SE1 7EH

  • ImClone Investigational Site

    Sutton, SM2 5PT

  • ImClone Investigational Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Canada3 sites

  • ImClone Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • ImClone Investigational Site

    Montreal, Quebec, H2L 4M1

  • ImClone Investigational Site

    Sherbrooke, Quebec, J1G 2E8

Other trials in Canada

Chile3 sites

  • ImClone Investigational Site

    Concepción, 407-0038

  • ImClone Investigational Site

    La Serena

  • ImClone Investigational Site

    Santiago, 6570917

Other trials in Chile

Poland3 sites

  • ImClone Investigational Site

    Gdansk, 80-219

  • ImClone Investigational Site

    Krakow, 31-108

  • ImClone Investigational Site

    Olsztyn, 10-513

Other trials in Poland

Thailand3 sites

  • ImClone Investigational Site

    Bangkok, 10400

  • ImClone Investigational Site

    Chiang Mai, 50002

  • ImClone Investigational Site

    Rajathevee District, 10400

Other trials in Thailand

Egypt2 sites

  • ImClone Investigational Site

    Alexandria, 21131

  • ImClone Investigational Site

    Cairo, 11796

Other trials in Egypt

Guatemala2 sites

  • ImClone Investigational Site

    Guatemala City, 01010

  • ImClone Investigational Site

    Guatemala City

Other trials in Guatemala

Malta2 sites

  • ImClone Investigational Site

    Floriana, 1941

  • ImClone Investigational Site

    Floriana, FRN 1941

Other trials in Malta

Philippines2 sites

  • ImClone Investigational Site

    Cebu City, 6000

  • ImClone Investigational Site

    Pasig, 1604

Other trials in Philippines

Bosnia and Herzegovina1 site

  • ImClone Investigational Site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Colombia1 site

  • ImClone Investigational Site

    Montería

Other trials in Colombia

Lebanon1 site

  • ImClone Investigational Site

    Beirut

Other trials in Lebanon

Mexico1 site

  • ImClone Investigational Site

    Aguascelientes, 20217

Other trials in Mexico

New Zealand1 site

  • ImClone Investigational Site

    Christchurch, 8011

Other trials in New Zealand

South Africa1 site

  • ImClone Investigational Site

    Cape Town, 7925

Other trials in South Africa

About this study

Official title: 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

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.

Read the detailed description

Placebo-controlled, multicenter Phase 3 study of participants with metastatic gastric cancer [including adenocarcinomas of the gastroesophageal junction (GEJ)] and disease progression on standard first-line chemotherapeutic regimens. Participants will be randomized on a 2:1 basis to receive best supportive care plus ramucirumab administered every 2 weeks or best supportive care plus placebo administered every 2 weeks, respectively. Participants will undergo radiographic assessment of disease status every 6 weeks. Participant will be treated until there is evidence of progressive disease, toxicity requiring cessation, withdrawal of consent, or until other withdrawal criteria are met.

Approximately 348 participants, with histologically- or cytologically-confirmed, metastatic gastric or GEJ adenocarcinoma, and radiographically measurable disease as defined by the Response Evaluation Criteria in Solid Tumors or evaluable, nonmeasurable disease, will be randomized. Participants will be enrolled from approximately 250 study centers in North America, South America, Central America, Asia, Australia, New Zealand, and Europe.

Being tested
ramucirumab, Placebo, Best Supportive Care (BSC)
Keywords
IMC-1121B, Monoclonal antibody (MAb), Vascular endothelial growth factor (VEGF), Human vascular endothelial growth factor receptor-2 (VEGFR-2), Platinum resistant, platinum refractory, Gastric, Gastroesophageal Junction Adenocarcinoma, metastatic, Angiogenesis
Medical subject headings
Stomach Neoplasms, Adenocarcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ramucirumabBiological

    Also called IMC-1121B, LY3009806

    Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg

  • PlaceboDrug

    Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

  • Best Supportive Care (BSC)Other

    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.

Study groups in NCT00917384
Study groupRoleWhat they receive
ramucirumabExperimentalParticipants 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.
Receives: Biological: ramucirumab; Other: Best Supportive Care (BSC)
PlaceboPlacebo 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.
Receives: Drug: Placebo; Other: Best Supportive Care (BSC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Randomization up to 28 months post-randomization

Secondary outcomes (8)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).

    Measured: Randomization up to 17 months

  2. Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)

    The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.

    Measured: Week 12 post-randomization

  3. Percentage of Participants With Objective Response (Objective Response Rate [ORR])

    ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.

    Measured: Randomization up to 17 months post-randomization

  4. Duration of Response (DOR)

    DOR is the interval from date of initial documented response (complete response [CR] or partial response [PR]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.

    Measured: Randomization up to 17 months post-randomization

  5. Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)

    EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.

    Measured: Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])

  6. Number of Participants With Adverse Events

    Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.

    Measured: Randomization up to 18 months

  7. Maximum Concentration (Cmax) of IMC-1121B

    Cmax was not analyzed as only pre-dose samples were collected.

    Measured: 6 weeks post-randomization

  8. Number of Participants Who Developed Antibodies Against IMC-1121B

    The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.

    Measured: Baseline, 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJul 2012
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00917384
Sponsor's protocol ID
13893
Other IDs
2008-005964-15, CP12-0715, I4T-IE-JVBD, 2008
Status last verified
Sep 2019
First submitted
8 Jun 2009
Last updated
25 Sep 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30557792

  • Tabernero 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.

    PubMed 28716815

  • Fuchs 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.

    PubMed 24094768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ramucirumab in people with Gastric Cancer and Adenocarcinoma, run by Eli Lilly and Company at 161 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in India, Brazil, United States, Italy, Czechia and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization up to 28 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00917384, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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Clinical Trial NCT00917384 | AzTrials