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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00917384
Registration number
NCT00917384
Ethics application status
Date submitted
8/06/2009
Date registered
10/06/2009
Date last updated
25/09/2019
Titles & IDs
Public title
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
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Scientific 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
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Secondary ID [1]
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2008-005964-15
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Secondary ID [2]
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13893
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
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Adenocarcinoma
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Condition category
Condition code
Cancer
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - ramucirumab
Treatment: Drugs - Placebo
Other interventions - Best Supportive Care (BSC)
Experimental: ramucirumab - Participants 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 Comparator: Placebo - Participants 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.
Other interventions: ramucirumab
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
Treatment: Drugs: Placebo
Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks
Other interventions: Best Supportive Care (BSC)
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.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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
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Timepoint [1]
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Randomization up to 28 months post-randomization
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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).
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Timepoint [1]
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Randomization up to 17 months
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Secondary outcome [2]
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Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12 post-randomization
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Secondary outcome [3]
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Percentage of Participants With Objective Response (Objective Response Rate [ORR])
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Assessment method [3]
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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.
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Timepoint [3]
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Randomization up to 17 months post-randomization
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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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.
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Timepoint [4]
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Randomization up to 17 months post-randomization
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Secondary outcome [5]
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Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
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Secondary outcome [6]
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Number of Participants With Adverse Events
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Assessment method [6]
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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.
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Timepoint [6]
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Randomization up to 18 months
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Secondary outcome [7]
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Maximum Concentration (Cmax) of IMC-1121B
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Assessment method [7]
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Cmax was not analyzed as only pre-dose samples were collected.
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Timepoint [7]
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6 weeks post-randomization
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Secondary outcome [8]
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Number of Participants Who Developed Antibodies Against IMC-1121B
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Assessment method [8]
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The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
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Timepoint [8]
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Baseline, 12 Weeks
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Eligibility
Key inclusion criteria
- 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
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
355
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
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Recruitment hospital [1]
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ImClone Investigational Site - Wodonga
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ImClone Investigational Site - Hobart
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ImClone Investigational Site - East Melbourne
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ImClone Investigational Site - Perth
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ImClone Investigational Site - Bedford Park
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Recruitment hospital [6]
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ImClone Investigational Site - St. Leonards
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Recruitment hospital [7]
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ImClone Investigational Site - Woodville
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Recruitment postcode(s) [1]
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3690 - Wodonga
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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NSW 2065 - St. Leonards
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Recruitment postcode(s) [7]
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5011 - Woodville
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Recruitment outside Australia
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United States of America
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California
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Illinois
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Rosario
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Sarajevo
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Indonesia
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Jakarta
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Lucca
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Russian Federation
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Turkey
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Gaziantep
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United Kingdom
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00917384
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Contacts
Principal investigator
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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)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00917384
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