이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2019년 9월 10일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

355

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 과테말라
      • Guatemala, 과테말라, 01010
        • ImClone Investigational Site
      • Guatemala, 과테말라
        • ImClone Investigational Site
  • 남아프리카
      • Cape Town, 남아프리카, 7925
        • ImClone Investigational Site
  • 뉴질랜드
      • Christchurch, 뉴질랜드, 8011
        • ImClone Investigational Site
  • 대만
      • Kaohsiung, 대만, 807
        • ImClone Investigational Site
      • Taichung County, 대만, 433
        • ImClone Investigational Site
      • Taipei, 대만, 111
        • ImClone Investigational Site
      • Taipei, 대만, 116
        • ImClone Investigational Site
  • 대한민국
      • Seoul, 대한민국, 120-752
        • ImClone Investigational Site
      • Seoul, 대한민국, 135-720
        • ImClone Investigational Site
      • Seoul, 대한민국, 136-705
        • ImClone Investigational Site
      • Seoul, 대한민국, 137-701
        • ImClone Investigational Site
  • 러시아 연방
      • Chelyabinsk, 러시아 연방, 454087
        • ImClone Investigational Site
      • Kursk, 러시아 연방, 305035
        • ImClone Investigational Site
      • Moscow, 러시아 연방, 115478
        • ImClone Investigational Site
      • Moscow, 러시아 연방, 125367
        • ImClone Investigational Site
      • Pyatigorsk, 러시아 연방, 357524
        • ImClone Investigational Site
      • St. Petersburg, 러시아 연방, 197022
        • ImClone Investigational Site
      • St. Petersburg, 러시아 연방, 197758
        • ImClone Investigational Site
      • St. Petersburg, 러시아 연방, 195067
        • ImClone Investigational Site
  • 레바논
      • Beirut, 레바논
        • ImClone Investigational Site
  • 루마니아
      • Baia Mare, 루마니아, 430031
        • ImClone Investigational Site
      • Cluj Napoca, 루마니아, 400015
        • ImClone Investigational Site
      • Cluj Napoca, 루마니아, 400058
        • ImClone Investigational Site
      • Suceava, 루마니아, 720237
        • ImClone Investigational Site
  • 멕시코
      • Aguascelientes, 멕시코, 20217
        • ImClone Investigational Site
  • 몰타
      • Floriana, 몰타, 1941
        • ImClone Investigational Site
      • Floriana, 몰타, FRN 1941
        • ImClone Investigational Site
  • 미국
    • California
      • Bakersfield, California, 미국, 93309
        • ImClone Investigational Site
      • La Jolla, California, 미국, 92093
        • ImClone Investigational Site
      • Redlands, California, 미국, 92374
        • ImClone Investigational Site
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • ImClone Investigational Site
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • ImClone Investigational Site
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • ImClone Investigational Site
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • ImClone Investigational Site
    • New York
      • New York, New York, 미국, 10003
        • ImClone Investigational Site
    • Pennsylvania
      • West Reading, Pennsylvania, 미국, 19611
        • ImClone Investigational Site
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • ImClone Investigational Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • ImClone Investigational Site
    • Tennessee
      • Knoxville, Tennessee, 미국, 37920
        • ImClone Investigational Site
      • Memphis, Tennessee, 미국, 38119
        • ImClone Investigational Site
    • Texas
      • Houston, Texas, 미국, 77030
        • ImClone Investigational Site
  • 보스니아 헤르체고비나
      • Sarajevo, 보스니아 헤르체고비나, 71000
        • ImClone Investigational Site
  • 브라질
      • Barretos, 브라질, 14784-400
        • ImClone Investigational Site
      • Belo Horizonte, 브라질, 30150-281
        • ImClone Investigational Site
      • Belo Horizonte, 브라질, 30110-090
        • ImClone Investigational Site
      • Brasilia, 브라질, 70390-150
        • ImClone Investigational Site
      • Curitiba, 브라질, 80730-130
        • ImClone Investigational Site
      • Curitiba, 브라질, 81520-060
        • ImClone Investigational Site
      • Florianopolis, 브라질, 88034-000
        • ImClone Investigational Site
      • Ijui, 브라질, 98700-000
        • ImClone Investigational Site
      • Lajeados, 브라질, 95900-000
        • ImClone Investigational Site
      • Londrina, 브라질, 86050-190
        • ImClone Investigational Site
      • Passo Fundo, 브라질, 99010-260
        • ImClone Investigational Site
      • Porto Alegre, 브라질, 90035-903
        • ImClone Investigational Site
      • Porto Alegre, 브라질, 90610-970
        • ImClone Investigational Site
      • Porto Alegre, 브라질, 90840-440
        • ImClone Investigational Site
      • Sao Paulo, 브라질, 01406-100
        • ImClone Investigational Site
  • 스페인
      • Alcorcon, 스페인, 28922
        • ImClone Investigational Site
      • Barcelona, 스페인, 08036
        • ImClone Investigational Site
      • Barcelona, 스페인, 08035
        • ImClone Investigational Site
      • Elche, 스페인, 03203
        • ImClone Investigational Site
      • Madrid, 스페인, 28034
        • ImClone Investigational Site
      • Santander, 스페인, 39008
        • ImClone Investigational Site
      • Sevilla, 스페인, 41021
        • ImClone Investigational Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나, 1425
        • ImClone Investigational Site
      • Capital Federal, 아르헨티나, 1264
        • ImClone Investigational Site
      • Ciudad Autonoma de Buenos Aires, 아르헨티나, C1437JCP
        • ImClone Investigational Site
      • Ciudada Autonoma, 아르헨티나, C1199ABD
        • ImClone Investigational Site
      • Cordoba, 아르헨티나, 5000
        • ImClone Investigational Site
      • Rosario, 아르헨티나, S2002KDS
        • ImClone Investigational Site
  • 영국
      • London, 영국, SE1 7EH
        • ImClone Investigational Site
      • Sutton, 영국, SM2 5PT
        • ImClone Investigational Site
      • Wolverhampton, 영국, WV10 0QP
        • ImClone Investigational Site
    • Wirral
      • Bebington, Wirral, 영국, L83 4JY
        • ImClone Investigational Site
  • 이집트
      • Alexandria, 이집트, 21131
        • ImClone Investigational Site
      • Cairo, 이집트, 11796
        • ImClone Investigational Site
  • 이탈리아
      • Aviano, 이탈리아, 33081
        • ImClone Investigational Site
      • Bologna, 이탈리아, 40138
        • ImClone Investigational Site
      • Brescia, 이탈리아, 25123
        • ImClone Investigational Site
      • Cremona, 이탈리아, 26100
        • ImClone Investigational Site
      • Lido di Camaiore, 이탈리아, 55043
        • ImClone Investigational Site
      • Lucca, 이탈리아, 55043
        • ImClone Investigational Site
      • Meldola, 이탈리아, 47014
        • ImClone Investigational Site
      • Mirano, 이탈리아, 30035
        • ImClone Investigational Site
      • Noale, 이탈리아, 30033
        • ImClone Investigational Site
      • Potenza, 이탈리아, 85100
        • ImClone Investigational Site
      • Rimini, 이탈리아, 47900
        • ImClone Investigational Site
      • Udine, 이탈리아, 33100
        • ImClone Investigational Site
  • 인도
      • Bangalore, 인도, 560 029
        • ImClone Investigational Site
      • Chennai, 인도, 600010
        • ImClone Investigational Site
      • Hyderabad, 인도, 500 033
        • ImClone Investigational Site
      • Hyderabad, 인도, 500004
        • ImClone Investigational Site
      • Kolkata, 인도, 700053
        • ImClone Investigational Site
      • Mumbai, 인도, 400 012
        • ImClone Investigational Site
      • Mumbai, 인도, 400016
        • ImClone Investigational Site
      • Pune, 인도, 411001
        • ImClone Investigational Site
      • West Bengal, 인도, 700054
        • ImClone Investigational Site
    • Andh Prad
      • Hyderabad, Andh Prad, 인도, 500004
        • ImClone Investigational Site
      • Hyderabad, Andh Prad, 인도, 500033
        • ImClone Investigational Site
    • Delhi
      • New Delhi, Delhi, 인도, 110085
        • ImClone Investigational Site
    • Karna
      • Bangalore, Karna, 인도, 560 025
        • ImClone Investigational Site
      • Bangalore, Karna, 인도, 560054
        • ImClone Investigational Site
    • Kerala
      • Cochin, Kerala, 인도, 682304
        • ImClone Investigational Site
      • Thiruvananthapuram, Kerala, 인도, 695011
        • ImClone Investigational Site
      • Trivandrum, Kerala, 인도, 695011
        • ImClone Investigational Site
    • Kilpauk
      • Chennai, Kilpauk, 인도, 600 010
        • ImClone Investigational Site
    • Madh Prad
      • Bhopal, Madh Prad, 인도, 462001
        • ImClone Investigational Site
      • Indore, Madh Prad, 인도, 452008
        • ImClone Investigational Site
    • Mahara
      • Mumbai, Mahara, 인도, 400016
        • ImClone Investigational Site
      • Nashik, Mahara, 인도, 422 004
        • ImClone Investigational Site
      • Pune, Mahara, 인도, 411001
        • ImClone Investigational Site
    • Tamilnadu
      • Chennai, Tamilnadu, 인도, 600010
        • ImClone Investigational Site
      • Chennai, Tamilnadu, 인도, 600035
        • ImClone Investigational Site
    • W Bengal
      • Kolkata, W Bengal, 인도, 700053
        • ImClone Investigational Site
      • Kolkata, W Bengal, 인도, 700054
        • ImClone Investigational Site
  • 인도네시아
      • Jakarta, 인도네시아, 10440
        • ImClone Investigational Site
      • Jakarta, 인도네시아, 11420
        • ImClone Investigational Site
      • Jakarta, 인도네시아, 14450
        • ImClone Investigational Site
      • Sumatera Utara, 인도네시아, 20136
        • ImClone Investigational Site
      • West Java, 인도네시아, 40161
        • ImClone Investigational Site
  • 체코
      • Brno, 체코, 656 53
        • ImClone Investigational Site
      • Hradec Kralove, 체코, 500 05
        • ImClone Investigational Site
      • Liberec, 체코, 460 63
        • ImClone Investigational Site
      • Nova Ves pod Plesi, 체코, 262 04
        • ImClone Investigational Site
      • Olomouc, 체코, 775 20
        • ImClone Investigational Site
      • Pardubice, 체코, 532 03
        • ImClone Investigational Site
      • Prague, 체코, 180 81
        • ImClone Investigational Site
      • Praha 10, 체코, 100 34
        • ImClone Investigational Site
      • Praha 2, 체코, 128 08
        • ImClone Investigational Site
      • Pribram, 체코, 261 95
        • ImClone Investigational Site
  • 칠레
      • Concepcion, 칠레, 407-0038
        • ImClone Investigational Site
      • La Serena, 칠레
        • ImClone Investigational Site
      • Santiago, 칠레, 6570917
        • ImClone Investigational Site
  • 칠면조
      • Adana, 칠면조, 01330
        • ImClone Investigational Site
      • Gaziantep, 칠면조, 27310
        • ImClone Investigational Site
      • Istanbul, 칠면조, 34718
        • ImClone Investigational Site
      • Izmir, 칠면조, 35100
        • ImClone Investigational Site
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • ImClone Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다, H2L 4M1
        • ImClone Investigational Site
      • Sherbrooke, Quebec, 캐나다, J1G 2E8
        • ImClone Investigational Site
  • 콜롬비아
      • Monteria, 콜롬비아
        • ImClone Investigational Site
  • 크로아티아
      • Osijek, 크로아티아, 31 100
        • ImClone Investigational Site
      • Pula, 크로아티아, 52100
        • ImClone Investigational Site
      • Slavonski Brod, 크로아티아, 35 000
        • ImClone Investigational Site
      • Zagreb, 크로아티아, 10 000
        • ImClone Investigational Site
  • 태국
      • Bangkok, 태국, 10400
        • ImClone Investigational Site
      • Chiang Mai, 태국, 50002
        • ImClone Investigational Site
      • Rajathevee District, 태국, 10400
        • ImClone Investigational Site
  • 폴란드
      • Gdansk, 폴란드, 80-219
        • ImClone Investigational Site
      • Krakow, 폴란드, 31-108
        • ImClone Investigational Site
      • Olsztyn, 폴란드, 10-513
        • ImClone Investigational Site
  • 필리핀 제도
      • Cebu City, 필리핀 제도, 6000
        • ImClone Investigational Site
      • Pasig City, 필리핀 제도, 1604
        • ImClone Investigational Site
  • 호주
      • Bedford Park, 호주, 5042
        • ImClone Investigational Site
      • St. Leonards, 호주, NSW 2065
        • ImClone Investigational Site
      • Woodville, 호주, 5011
        • ImClone Investigational Site
    • New South Wales
      • Wodonga, New South Wales, 호주, 3690
        • ImClone Investigational Site
    • Tasmania
      • Hobart, Tasmania, 호주, 7000
        • ImClone Investigational Site
    • Victoria
      • East Melbourne, Victoria, 호주, 3002
        • ImClone Investigational Site
    • Western Australia
      • Perth, Western Australia, 호주, 6000
        • ImClone Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: ramucirumab
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
다른 이름들:
  • LY3009806
  • IMC-1121B
다른: 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.
위약 비교기: 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.
다른: 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.
의약품: Placebo
Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS)
기간: 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)
기간: 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])
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: Baseline, 12 Weeks
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Baseline, 12 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 8월 1일

기본 완료 (실제)

2012년 7월 1일

연구 완료 (실제)

2015년 12월 1일

연구 등록 날짜

최초 제출

2009년 6월 8일

QC 기준을 충족하는 최초 제출

2009년 6월 9일

처음 게시됨 (추정)

2009년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 9월 10일

마지막으로 확인됨

2019년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 13893
  • 2008-005964-15 (레지스트리 식별자: MHRA)
  • CP12-0715 (기타 식별자: ImClone Systems)
  • I4T-IE-JVBD (기타 식별자: Eli Lilly and Company)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

선암종에 대한 임상 시험

ramucirumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Lebanon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다