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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00917384




Registration number
NCT00917384
Ethics application status
Date submitted
8/06/2009
Date registered
10/06/2009

Titles & IDs
Public title
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
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
Secondary ID [1] 0 0
2008-005964-15
Secondary ID [2] 0 0
13893
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization up to 28 months post-randomization
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Randomization up to 17 months
Secondary outcome [2] 0 0
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
Timepoint [2] 0 0
Week 12 post-randomization
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response (Objective Response Rate [ORR])
Timepoint [3] 0 0
Randomization up to 17 months post-randomization
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Randomization up to 17 months post-randomization
Secondary outcome [5] 0 0
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Timepoint [5] 0 0
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
Secondary outcome [6] 0 0
Number of Participants With Adverse Events
Timepoint [6] 0 0
Randomization up to 18 months
Secondary outcome [7] 0 0
Maximum Concentration (Cmax) of IMC-1121B
Timepoint [7] 0 0
6 weeks post-randomization
Secondary outcome [8] 0 0
Number of Participants Who Developed Antibodies Against IMC-1121B
Timepoint [8] 0 0
Baseline, 12 Weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
355
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
Recruitment hospital [1] 0 0
ImClone Investigational Site - Wodonga
Recruitment hospital [2] 0 0
ImClone Investigational Site - Hobart
Recruitment hospital [3] 0 0
ImClone Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
ImClone Investigational Site - Perth
Recruitment hospital [5] 0 0
ImClone Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
ImClone Investigational Site - St. Leonards
Recruitment hospital [7] 0 0
ImClone Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
3690 - Wodonga
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
NSW 2065 - St. Leonards
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment outside Australia
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United States of America
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California
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United States of America
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Illinois
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Louisiana
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Massachusetts
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United States of America
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Nebraska
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New York
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Capital Federal
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Ciudada Autonoma
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Argentina
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Cordoba
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Argentina
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Rosario
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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Barretos
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Brazil
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Belo Horizonte
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Brazil
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Brasilia
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
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Ijui
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Brazil
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Lajeados
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Brazil
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Londrina
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Porto Alegre
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Sao Paulo
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Alberta
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Chile
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Concepcion
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Chile
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La Serena
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Chile
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Santiago
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Monteria
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Osijek
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Pula
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Brno
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Hradec Kralove
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Liberec
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Czechia
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Nova Ves pod Plesi
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Olomouc
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Pardubice
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Prague
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Praha 10
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Praha 2
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Pribram
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Mahara
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Tamilnadu
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W Bengal
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Bangalore
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Chennai
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Hyderabad
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Kolkata
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Mumbai
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Pune
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West Bengal
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Indonesia
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Jakarta
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Indonesia
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Sumatera Utara
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Indonesia
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West Java
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Italy
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Aviano
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Cremona
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Italy
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Lido di Camaiore
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Italy
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Lucca
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Italy
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Meldola
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Italy
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Mirano
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Italy
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Noale
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Italy
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Potenza
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Italy
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Rimini
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Italy
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Udine
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Korea, Republic of
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Seoul
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Lebanon
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Floriana
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Mexico
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Aguascelientes
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Christchurch
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Cebu City
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Philippines
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Pasig City
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Poland
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Gdansk
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Krakow
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Olsztyn
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Romania
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Baia Mare
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Romania
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Cluj Napoca
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Romania
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Suceava
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Pyatigorsk
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Russian Federation
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St. Petersburg
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South Africa
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Cape Town
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Spain
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Alcorcon
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla
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Taiwan
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Kaohsiung
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Taiwan
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Taichung County
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Rajathevee District
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Turkey
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Adana
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Wirral
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United Kingdom
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London
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United Kingdom
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Sutton
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00917384