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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

355

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Bakersfield、California、アメリカ、93309
        • ImClone Investigational Site
      • La Jolla、California、アメリカ、92093
        • ImClone Investigational Site
      • Redlands、California、アメリカ、92374
        • ImClone Investigational Site
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • ImClone Investigational Site
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70112
        • ImClone Investigational Site
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • ImClone Investigational Site
    • Nebraska
      • Omaha、Nebraska、アメリカ、68114
        • ImClone Investigational Site
    • New York
      • New York、New York、アメリカ、10003
        • ImClone Investigational Site
    • Pennsylvania
      • West Reading、Pennsylvania、アメリカ、19611
        • ImClone Investigational Site
    • Rhode Island
      • Providence、Rhode Island、アメリカ、02903
        • ImClone Investigational Site
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • ImClone Investigational Site
    • Tennessee
      • Knoxville、Tennessee、アメリカ、37920
        • ImClone Investigational Site
      • Memphis、Tennessee、アメリカ、38119
        • ImClone Investigational Site
    • Texas
      • Houston、Texas、アメリカ、77030
        • ImClone Investigational Site
  • アルゼンチン
      • Buenos Aires、アルゼンチン、1425
        • ImClone Investigational Site
      • Capital Federal、アルゼンチン、1264
        • ImClone Investigational Site
      • Ciudad Autonoma de Buenos Aires、アルゼンチン、C1437JCP
        • ImClone Investigational Site
      • Ciudada Autonoma、アルゼンチン、C1199ABD
        • ImClone Investigational Site
      • Cordoba、アルゼンチン、5000
        • ImClone Investigational Site
      • Rosario、アルゼンチン、S2002KDS
        • ImClone Investigational Site
  • イギリス
      • London、イギリス、SE1 7EH
        • ImClone Investigational Site
      • Sutton、イギリス、SM2 5PT
        • ImClone Investigational Site
      • Wolverhampton、イギリス、WV10 0QP
        • ImClone Investigational Site
    • Wirral
      • Bebington、Wirral、イギリス、L83 4JY
        • ImClone Investigational Site
  • イタリア
      • Aviano、イタリア、33081
        • ImClone Investigational Site
      • Bologna、イタリア、40138
        • ImClone Investigational Site
      • Brescia、イタリア、25123
        • ImClone Investigational Site
      • Cremona、イタリア、26100
        • ImClone Investigational Site
      • Lido di Camaiore、イタリア、55043
        • ImClone Investigational Site
      • Lucca、イタリア、55043
        • ImClone Investigational Site
      • Meldola、イタリア、47014
        • ImClone Investigational Site
      • Mirano、イタリア、30035
        • ImClone Investigational Site
      • Noale、イタリア、30033
        • ImClone Investigational Site
      • Potenza、イタリア、85100
        • ImClone Investigational Site
      • Rimini、イタリア、47900
        • ImClone Investigational Site
      • Udine、イタリア、33100
        • ImClone Investigational Site
  • インド
      • Bangalore、インド、560 029
        • ImClone Investigational Site
      • Chennai、インド、600010
        • ImClone Investigational Site
      • Hyderabad、インド、500 033
        • ImClone Investigational Site
      • Hyderabad、インド、500004
        • ImClone Investigational Site
      • Kolkata、インド、700053
        • ImClone Investigational Site
      • Mumbai、インド、400 012
        • ImClone Investigational Site
      • Mumbai、インド、400016
        • ImClone Investigational Site
      • Pune、インド、411001
        • ImClone Investigational Site
      • West Bengal、インド、700054
        • ImClone Investigational Site
    • Andh Prad
      • Hyderabad、Andh Prad、インド、500004
        • ImClone Investigational Site
      • Hyderabad、Andh Prad、インド、500033
        • ImClone Investigational Site
    • Delhi
      • New Delhi、Delhi、インド、110085
        • ImClone Investigational Site
    • Karna
      • Bangalore、Karna、インド、560 025
        • ImClone Investigational Site
      • Bangalore、Karna、インド、560054
        • ImClone Investigational Site
    • Kerala
      • Cochin、Kerala、インド、682304
        • ImClone Investigational Site
      • Thiruvananthapuram、Kerala、インド、695011
        • ImClone Investigational Site
      • Trivandrum、Kerala、インド、695011
        • ImClone Investigational Site
    • Kilpauk
      • Chennai、Kilpauk、インド、600 010
        • ImClone Investigational Site
    • Madh Prad
      • Bhopal、Madh Prad、インド、462001
        • ImClone Investigational Site
      • Indore、Madh Prad、インド、452008
        • ImClone Investigational Site
    • Mahara
      • Mumbai、Mahara、インド、400016
        • ImClone Investigational Site
      • Nashik、Mahara、インド、422 004
        • ImClone Investigational Site
      • Pune、Mahara、インド、411001
        • ImClone Investigational Site
    • Tamilnadu
      • Chennai、Tamilnadu、インド、600010
        • ImClone Investigational Site
      • Chennai、Tamilnadu、インド、600035
        • ImClone Investigational Site
    • W Bengal
      • Kolkata、W Bengal、インド、700053
        • ImClone Investigational Site
      • Kolkata、W Bengal、インド、700054
        • ImClone Investigational Site
  • インドネシア
      • Jakarta、インドネシア、10440
        • ImClone Investigational Site
      • Jakarta、インドネシア、11420
        • ImClone Investigational Site
      • Jakarta、インドネシア、14450
        • ImClone Investigational Site
      • Sumatera Utara、インドネシア、20136
        • ImClone Investigational Site
      • West Java、インドネシア、40161
        • ImClone Investigational Site
  • エジプト
      • Alexandria、エジプト、21131
        • ImClone Investigational Site
      • Cairo、エジプト、11796
        • ImClone Investigational Site
  • オーストラリア
      • Bedford Park、オーストラリア、5042
        • ImClone Investigational Site
      • St. Leonards、オーストラリア、NSW 2065
        • ImClone Investigational Site
      • Woodville、オーストラリア、5011
        • ImClone Investigational Site
    • New South Wales
      • Wodonga、New South Wales、オーストラリア、3690
        • ImClone Investigational Site
    • Tasmania
      • Hobart、Tasmania、オーストラリア、7000
        • ImClone Investigational Site
    • Victoria
      • East Melbourne、Victoria、オーストラリア、3002
        • ImClone Investigational Site
    • Western Australia
      • Perth、Western Australia、オーストラリア、6000
        • ImClone Investigational Site
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • ImClone Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ、H2L 4M1
        • ImClone Investigational Site
      • Sherbrooke、Quebec、カナダ、J1G 2E8
        • ImClone Investigational Site
  • クロアチア
      • Osijek、クロアチア、31 100
        • ImClone Investigational Site
      • Pula、クロアチア、52100
        • ImClone Investigational Site
      • Slavonski Brod、クロアチア、35 000
        • ImClone Investigational Site
      • Zagreb、クロアチア、10 000
        • ImClone Investigational Site
  • グアテマラ
      • Guatemala、グアテマラ、01010
        • ImClone Investigational Site
      • Guatemala、グアテマラ
        • ImClone Investigational Site
  • コロンビア
      • Monteria、コロンビア
        • ImClone Investigational Site
  • スペイン
      • Alcorcon、スペイン、28922
        • ImClone Investigational Site
      • Barcelona、スペイン、08036
        • ImClone Investigational Site
      • Barcelona、スペイン、08035
        • ImClone Investigational Site
      • Elche、スペイン、03203
        • ImClone Investigational Site
      • Madrid、スペイン、28034
        • ImClone Investigational Site
      • Santander、スペイン、39008
        • ImClone Investigational Site
      • Sevilla、スペイン、41021
        • ImClone Investigational Site
  • タイ
      • Bangkok、タイ、10400
        • ImClone Investigational Site
      • Chiang Mai、タイ、50002
        • ImClone Investigational Site
      • Rajathevee District、タイ、10400
        • ImClone Investigational Site
  • チェコ
      • Brno、チェコ、656 53
        • ImClone Investigational Site
      • Hradec Kralove、チェコ、500 05
        • ImClone Investigational Site
      • Liberec、チェコ、460 63
        • ImClone Investigational Site
      • Nova Ves pod Plesi、チェコ、262 04
        • ImClone Investigational Site
      • Olomouc、チェコ、775 20
        • ImClone Investigational Site
      • Pardubice、チェコ、532 03
        • ImClone Investigational Site
      • Prague、チェコ、180 81
        • ImClone Investigational Site
      • Praha 10、チェコ、100 34
        • ImClone Investigational Site
      • Praha 2、チェコ、128 08
        • ImClone Investigational Site
      • Pribram、チェコ、261 95
        • ImClone Investigational Site
  • チリ
      • Concepcion、チリ、407-0038
        • ImClone Investigational Site
      • La Serena、チリ
        • ImClone Investigational Site
      • Santiago、チリ、6570917
        • ImClone Investigational Site
  • ニュージーランド
      • Christchurch、ニュージーランド、8011
        • ImClone Investigational Site
  • フィリピン
      • Cebu City、フィリピン、6000
        • ImClone Investigational Site
      • Pasig City、フィリピン、1604
        • ImClone Investigational Site
  • ブラジル
      • Barretos、ブラジル、14784-400
        • ImClone Investigational Site
      • Belo Horizonte、ブラジル、30150-281
        • ImClone Investigational Site
      • Belo Horizonte、ブラジル、30110-090
        • ImClone Investigational Site
      • Brasilia、ブラジル、70390-150
        • ImClone Investigational Site
      • Curitiba、ブラジル、80730-130
        • ImClone Investigational Site
      • Curitiba、ブラジル、81520-060
        • ImClone Investigational Site
      • Florianopolis、ブラジル、88034-000
        • ImClone Investigational Site
      • Ijui、ブラジル、98700-000
        • ImClone Investigational Site
      • Lajeados、ブラジル、95900-000
        • ImClone Investigational Site
      • Londrina、ブラジル、86050-190
        • ImClone Investigational Site
      • Passo Fundo、ブラジル、99010-260
        • ImClone Investigational Site
      • Porto Alegre、ブラジル、90035-903
        • ImClone Investigational Site
      • Porto Alegre、ブラジル、90610-970
        • ImClone Investigational Site
      • Porto Alegre、ブラジル、90840-440
        • ImClone Investigational Site
      • Sao Paulo、ブラジル、01406-100
        • ImClone Investigational Site
  • ボスニア・ヘルツェゴビナ
      • Sarajevo、ボスニア・ヘルツェゴビナ、71000
        • ImClone Investigational Site
  • ポーランド
      • Gdansk、ポーランド、80-219
        • ImClone Investigational Site
      • Krakow、ポーランド、31-108
        • ImClone Investigational Site
      • Olsztyn、ポーランド、10-513
        • ImClone Investigational Site
  • マルタ
      • Floriana、マルタ、1941
        • ImClone Investigational Site
      • Floriana、マルタ、FRN 1941
        • ImClone Investigational Site
  • メキシコ
      • Aguascelientes、メキシコ、20217
        • ImClone Investigational Site
  • ルーマニア
      • Baia Mare、ルーマニア、430031
        • ImClone Investigational Site
      • Cluj Napoca、ルーマニア、400015
        • ImClone Investigational Site
      • Cluj Napoca、ルーマニア、400058
        • ImClone Investigational Site
      • Suceava、ルーマニア、720237
        • ImClone Investigational Site
  • レバノン
      • Beirut、レバノン
        • ImClone Investigational Site
  • ロシア連邦
      • Chelyabinsk、ロシア連邦、454087
        • ImClone Investigational Site
      • Kursk、ロシア連邦、305035
        • ImClone Investigational Site
      • Moscow、ロシア連邦、115478
        • ImClone Investigational Site
      • Moscow、ロシア連邦、125367
        • ImClone Investigational Site
      • Pyatigorsk、ロシア連邦、357524
        • ImClone Investigational Site
      • St. Petersburg、ロシア連邦、197022
        • ImClone Investigational Site
      • St. Petersburg、ロシア連邦、197758
        • ImClone Investigational Site
      • St. Petersburg、ロシア連邦、195067
        • ImClone Investigational Site
  • 七面鳥
      • Adana、七面鳥、01330
        • ImClone Investigational Site
      • Gaziantep、七面鳥、27310
        • ImClone Investigational Site
      • Istanbul、七面鳥、34718
        • ImClone Investigational Site
      • Izmir、七面鳥、35100
        • ImClone Investigational Site
  • 南アフリカ
      • Cape Town、南アフリカ、7925
        • 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
  • 大韓民国
      • Seoul、大韓民国、120-752
        • ImClone Investigational Site
      • Seoul、大韓民国、135-720
        • ImClone Investigational Site
      • Seoul、大韓民国、136-705
        • ImClone Investigational Site
      • Seoul、大韓民国、137-701
        • ImClone Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：ramucirumab
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
他の名前：
  • LY3009806
  • IMC-1121B
他の：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.
プラセボコンパレーター：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.
他の：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.
薬：Placebo
Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-Free Survival (PFS)
時間枠：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)
時間枠：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])
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, 12 Weeks
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Baseline, 12 Weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Eli Lilly and Company

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年8月1日

一次修了 (実際)

2012年7月1日

研究の完了 (実際)

2015年12月1日

試験登録日

最初に提出

2009年6月8日

QC基準を満たした最初の提出物

2009年6月9日

最初の投稿 (見積もり)

2009年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2019年9月25日

QC基準を満たした最後の更新が送信されました

2019年9月10日

最終確認日

2019年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 13893
  • 2008-005964-15 (レジストリ識別子：MHRA)
  • CP12-0715 (その他の識別子：ImClone Systems)
  • I4T-IE-JVBD (その他の識別子：Eli Lilly and Company)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

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