此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2019年9月10日 更新者：Eli Lilly and Company

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

355

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦、454087
        • ImClone Investigational Site
      • Kursk、俄罗斯联邦、305035
        • ImClone Investigational Site
      • Moscow、俄罗斯联邦、115478
        • ImClone Investigational Site
      • Moscow、俄罗斯联邦、125367
        • ImClone Investigational Site
      • Pyatigorsk、俄罗斯联邦、357524
        • ImClone Investigational Site
      • St. Petersburg、俄罗斯联邦、197022
        • ImClone Investigational Site
      • St. Petersburg、俄罗斯联邦、197758
        • ImClone Investigational Site
      • St. Petersburg、俄罗斯联邦、195067
        • ImClone Investigational Site
  • 克罗地亚
      • Osijek、克罗地亚、31 100
        • ImClone Investigational Site
      • Pula、克罗地亚、52100
        • ImClone Investigational Site
      • Slavonski Brod、克罗地亚、35 000
        • ImClone Investigational Site
      • Zagreb、克罗地亚、10 000
        • ImClone Investigational Site
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • ImClone Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大、H2L 4M1
        • ImClone Investigational Site
      • Sherbrooke、Quebec、加拿大、J1G 2E8
        • ImClone Investigational Site
  • 南非
      • Cape Town、南非、7925
        • ImClone Investigational Site
  • 印度
      • Bangalore、印度、560 029
        • ImClone Investigational Site
      • Chennai、印度、600010
        • ImClone Investigational Site
      • Hyderabad、印度、500 033
        • ImClone Investigational Site
      • Hyderabad、印度、500004
        • ImClone Investigational Site
      • Kolkata、印度、700053
        • ImClone Investigational Site
      • Mumbai、印度、400 012
        • ImClone Investigational Site
      • Mumbai、印度、400016
        • ImClone Investigational Site
      • Pune、印度、411001
        • ImClone Investigational Site
      • West Bengal、印度、700054
        • ImClone Investigational Site
    • Andh Prad
      • Hyderabad、Andh Prad、印度、500004
        • ImClone Investigational Site
      • Hyderabad、Andh Prad、印度、500033
        • ImClone Investigational Site
    • Delhi
      • New Delhi、Delhi、印度、110085
        • ImClone Investigational Site
    • Karna
      • Bangalore、Karna、印度、560 025
        • ImClone Investigational Site
      • Bangalore、Karna、印度、560054
        • ImClone Investigational Site
    • Kerala
      • Cochin、Kerala、印度、682304
        • ImClone Investigational Site
      • Thiruvananthapuram、Kerala、印度、695011
        • ImClone Investigational Site
      • Trivandrum、Kerala、印度、695011
        • ImClone Investigational Site
    • Kilpauk
      • Chennai、Kilpauk、印度、600 010
        • ImClone Investigational Site
    • Madh Prad
      • Bhopal、Madh Prad、印度、462001
        • ImClone Investigational Site
      • Indore、Madh Prad、印度、452008
        • ImClone Investigational Site
    • Mahara
      • Mumbai、Mahara、印度、400016
        • ImClone Investigational Site
      • Nashik、Mahara、印度、422 004
        • ImClone Investigational Site
      • Pune、Mahara、印度、411001
        • ImClone Investigational Site
    • Tamilnadu
      • Chennai、Tamilnadu、印度、600010
        • ImClone Investigational Site
      • Chennai、Tamilnadu、印度、600035
        • ImClone Investigational Site
    • W Bengal
      • Kolkata、W Bengal、印度、700053
        • ImClone Investigational Site
      • Kolkata、W Bengal、印度、700054
        • ImClone Investigational Site
  • 印度尼西亚
      • Jakarta、印度尼西亚、10440
        • ImClone Investigational Site
      • Jakarta、印度尼西亚、11420
        • ImClone Investigational Site
      • Jakarta、印度尼西亚、14450
        • ImClone Investigational Site
      • Sumatera Utara、印度尼西亚、20136
        • ImClone Investigational Site
      • West Java、印度尼西亚、40161
        • ImClone Investigational Site
  • 危地马拉
      • Guatemala、危地马拉、01010
        • ImClone Investigational Site
      • Guatemala、危地马拉
        • ImClone Investigational Site
  • 台湾
      • Kaohsiung、台湾、807
        • ImClone Investigational Site
      • Taichung County、台湾、433
        • ImClone Investigational Site
      • Taipei、台湾、111
        • ImClone Investigational Site
      • Taipei、台湾、116
        • ImClone Investigational Site
  • 哥伦比亚
      • Monteria、哥伦比亚
        • ImClone Investigational Site
  • 埃及
      • Alexandria、埃及、21131
        • ImClone Investigational Site
      • Cairo、埃及、11796
        • ImClone Investigational Site
  • 墨西哥
      • Aguascelientes、墨西哥、20217
        • ImClone Investigational Site
  • 大韩民国
      • Seoul、大韩民国、120-752
        • ImClone Investigational Site
      • Seoul、大韩民国、135-720
        • ImClone Investigational Site
      • Seoul、大韩民国、136-705
        • ImClone Investigational Site
      • Seoul、大韩民国、137-701
        • ImClone Investigational Site
  • 巴西
      • Barretos、巴西、14784-400
        • ImClone Investigational Site
      • Belo Horizonte、巴西、30150-281
        • ImClone Investigational Site
      • Belo Horizonte、巴西、30110-090
        • ImClone Investigational Site
      • Brasilia、巴西、70390-150
        • ImClone Investigational Site
      • Curitiba、巴西、80730-130
        • ImClone Investigational Site
      • Curitiba、巴西、81520-060
        • ImClone Investigational Site
      • Florianopolis、巴西、88034-000
        • ImClone Investigational Site
      • Ijui、巴西、98700-000
        • ImClone Investigational Site
      • Lajeados、巴西、95900-000
        • ImClone Investigational Site
      • Londrina、巴西、86050-190
        • ImClone Investigational Site
      • Passo Fundo、巴西、99010-260
        • ImClone Investigational Site
      • Porto Alegre、巴西、90035-903
        • ImClone Investigational Site
      • Porto Alegre、巴西、90610-970
        • ImClone Investigational Site
      • Porto Alegre、巴西、90840-440
        • ImClone Investigational Site
      • Sao Paulo、巴西、01406-100
        • ImClone Investigational Site
  • 意大利
      • Aviano、意大利、33081
        • ImClone Investigational Site
      • Bologna、意大利、40138
        • ImClone Investigational Site
      • Brescia、意大利、25123
        • ImClone Investigational Site
      • Cremona、意大利、26100
        • ImClone Investigational Site
      • Lido di Camaiore、意大利、55043
        • ImClone Investigational Site
      • Lucca、意大利、55043
        • ImClone Investigational Site
      • Meldola、意大利、47014
        • ImClone Investigational Site
      • Mirano、意大利、30035
        • ImClone Investigational Site
      • Noale、意大利、30033
        • ImClone Investigational Site
      • Potenza、意大利、85100
        • ImClone Investigational Site
      • Rimini、意大利、47900
        • ImClone Investigational Site
      • Udine、意大利、33100
        • ImClone Investigational Site
  • 捷克语
      • Brno、捷克语、656 53
        • ImClone Investigational Site
      • Hradec Kralove、捷克语、500 05
        • ImClone Investigational Site
      • Liberec、捷克语、460 63
        • ImClone Investigational Site
      • Nova Ves pod Plesi、捷克语、262 04
        • ImClone Investigational Site
      • Olomouc、捷克语、775 20
        • ImClone Investigational Site
      • Pardubice、捷克语、532 03
        • ImClone Investigational Site
      • Prague、捷克语、180 81
        • ImClone Investigational Site
      • Praha 10、捷克语、100 34
        • ImClone Investigational Site
      • Praha 2、捷克语、128 08
        • ImClone Investigational Site
      • Pribram、捷克语、261 95
        • ImClone Investigational Site
  • 新西兰
      • Christchurch、新西兰、8011
        • ImClone Investigational Site
  • 智利
      • Concepcion、智利、407-0038
        • ImClone Investigational Site
      • La Serena、智利
        • ImClone Investigational Site
      • Santiago、智利、6570917
        • ImClone Investigational Site
  • 波兰
      • Gdansk、波兰、80-219
        • ImClone Investigational Site
      • Krakow、波兰、31-108
        • ImClone Investigational Site
      • Olsztyn、波兰、10-513
        • ImClone Investigational Site
  • 波斯尼亚和黑塞哥维那
      • Sarajevo、波斯尼亚和黑塞哥维那、71000
        • ImClone Investigational Site
  • 泰国
      • Bangkok、泰国、10400
        • ImClone Investigational Site
      • Chiang Mai、泰国、50002
        • ImClone Investigational Site
      • Rajathevee District、泰国、10400
        • ImClone Investigational Site
  • 澳大利亚
      • Bedford Park、澳大利亚、5042
        • ImClone Investigational Site
      • St. Leonards、澳大利亚、NSW 2065
        • ImClone Investigational Site
      • Woodville、澳大利亚、5011
        • ImClone Investigational Site
    • New South Wales
      • Wodonga、New South Wales、澳大利亚、3690
        • ImClone Investigational Site
    • Tasmania
      • Hobart、Tasmania、澳大利亚、7000
        • ImClone Investigational Site
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3002
        • ImClone Investigational Site
    • Western Australia
      • Perth、Western Australia、澳大利亚、6000
        • ImClone Investigational Site
  • 火鸡
      • Adana、火鸡、01330
        • ImClone Investigational Site
      • Gaziantep、火鸡、27310
        • ImClone Investigational Site
      • Istanbul、火鸡、34718
        • ImClone Investigational Site
      • Izmir、火鸡、35100
        • ImClone Investigational Site
  • 罗马尼亚
      • Baia Mare、罗马尼亚、430031
        • ImClone Investigational Site
      • Cluj Napoca、罗马尼亚、400015
        • ImClone Investigational Site
      • Cluj Napoca、罗马尼亚、400058
        • ImClone Investigational Site
      • Suceava、罗马尼亚、720237
        • ImClone Investigational Site
  • 美国
    • California
      • Bakersfield、California、美国、93309
        • ImClone Investigational Site
      • La Jolla、California、美国、92093
        • ImClone Investigational Site
      • Redlands、California、美国、92374
        • ImClone Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60612
        • ImClone Investigational Site
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • ImClone Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • ImClone Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • ImClone Investigational Site
    • New York
      • New York、New York、美国、10003
        • ImClone Investigational Site
    • Pennsylvania
      • West Reading、Pennsylvania、美国、19611
        • ImClone Investigational Site
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • ImClone Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • ImClone Investigational Site
    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • ImClone Investigational Site
      • Memphis、Tennessee、美国、38119
        • ImClone Investigational Site
    • Texas
      • Houston、Texas、美国、77030
        • ImClone Investigational Site
  • 英国
      • London、英国、SE1 7EH
        • ImClone Investigational Site
      • Sutton、英国、SM2 5PT
        • ImClone Investigational Site
      • Wolverhampton、英国、WV10 0QP
        • ImClone Investigational Site
    • Wirral
      • Bebington、Wirral、英国、L83 4JY
        • ImClone Investigational Site
  • 菲律宾
      • Cebu City、菲律宾、6000
        • ImClone Investigational Site
      • Pasig City、菲律宾、1604
        • ImClone Investigational Site
  • 西班牙
      • Alcorcon、西班牙、28922
        • ImClone Investigational Site
      • Barcelona、西班牙、08036
        • ImClone Investigational Site
      • Barcelona、西班牙、08035
        • ImClone Investigational Site
      • Elche、西班牙、03203
        • ImClone Investigational Site
      • Madrid、西班牙、28034
        • ImClone Investigational Site
      • Santander、西班牙、39008
        • ImClone Investigational Site
      • Sevilla、西班牙、41021
        • ImClone Investigational Site
  • 阿根廷
      • Buenos Aires、阿根廷、1425
        • ImClone Investigational Site
      • Capital Federal、阿根廷、1264
        • ImClone Investigational Site
      • Ciudad Autonoma de Buenos Aires、阿根廷、C1437JCP
        • ImClone Investigational Site
      • Ciudada Autonoma、阿根廷、C1199ABD
        • ImClone Investigational Site
      • Cordoba、阿根廷、5000
        • ImClone Investigational Site
      • Rosario、阿根廷、S2002KDS
        • ImClone Investigational Site
  • 马耳他
      • Floriana、马耳他、1941
        • ImClone Investigational Site
      • Floriana、马耳他、FRN 1941
        • ImClone Investigational Site
  • 黎巴嫩
      • Beirut、黎巴嫩
        • ImClone Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
生物：ramucirumab
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
其他名称：
  • LY3009806
  • IMC-1121B
其他：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.
安慰剂比较：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.
其他：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.
药品：Placebo
Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Randomization up to 28 months post-randomization
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

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS)
大体时间：Randomization up to 17 months
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).
Randomization up to 17 months
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
大体时间：Week 12 post-randomization
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.
Week 12 post-randomization
Percentage of Participants With Objective Response (Objective Response Rate [ORR])
大体时间：Randomization up to 17 months post-randomization
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.
Randomization up to 17 months post-randomization
Duration of Response (DOR)
大体时间：Randomization up to 17 months post-randomization
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.
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)
大体时间：Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
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.
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
Number of Participants With Adverse Events
大体时间：Randomization up to 18 months
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.
Randomization up to 18 months
Maximum Concentration (Cmax) of IMC-1121B
大体时间：6 weeks post-randomization
Cmax was not analyzed as only pre-dose samples were collected.
6 weeks post-randomization
Number of Participants Who Developed Antibodies Against IMC-1121B
大体时间：Baseline, 12 Weeks
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Baseline, 12 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年8月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2009年6月8日

首先提交符合 QC 标准的

2009年6月9日

首次发布 (估计)

2009年6月10日

研究记录更新

最后更新发布 (实际的)

2019年9月25日

上次提交的符合 QC 标准的更新

2019年9月10日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 13893
  • 2008-005964-15 (注册表标识符：MHRA)
  • CP12-0715 (其他标识符：ImClone Systems)
  • I4T-IE-JVBD (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

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.

IPD 共享访问标准

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅