A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer

Last updated: May 19, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Gastric Cancer

Gastric Ulcers

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02898077
15244
I4T-CR-JVCR
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 atstudy entry.
  • Have a histopathologically or cytologically confirmed diagnosis of gastric orgastroesophageal junction (GEJ) adenocarcinoma.
  • Have metastatic disease or locally advanced, unresectable disease.
  • Have at least 1 measurable lesion based on Response Evaluation Criteria in SolidTumors (RECIST), Version 1.1.
  • Have experienced documented objective radiographic or symptomatic disease progressionduring first-line therapy, or within 4 months after the last dose of first-linetherapy with any platinum/fluoropyrimidine doublet for unresectable or metastaticdisease.
  • Have adequate organ function.
  • Have urinary protein ≤1+ on dipstick or routine urinalysis.

Exclusion

Exclusion Criteria:

  • Have undergone major surgery within 28 days prior to randomization.
  • Have received any first-line chemotherapy other than platinum and fluoropyrimidinewith or without anthracycline for advanced gastric or GEJ adenocarcinoma.
  • Have received any previous systemic therapy (including investigational agents)targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signalingpathways.
  • Have a history of deep vein thrombosis, pulmonary embolism, or any other significantthromboembolism during the 3 months prior to randomization.
  • Have significant bleeding disorders, vasculitis, or had a significant bleeding episodefrom the gastrointestinal (GI) tract within 3 months prior to study entry.
  • Have a history of GI perforation and/or fistulae within 6 months prior torandomization.
  • Have experienced any arterial thromboembolic event within 6 months prior torandomization.
  • Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters ofmercury [mmHg] or diastolic blood pressure ≥100 mmHg) despite standard medicalmanagement.
  • Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 daysprior to randomization.
  • Have a serious illness or medical condition(s).

Study Design

Total Participants: 440
Study Start date:
March 02, 2017
Estimated Completion Date:
April 12, 2021

Connect with a study center

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing 100071
    China

    Site Not Available

  • Daping Hospital Of The 3rd Military Medical University

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • First hospital affiliated to Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Wuhan Union (Xiehe) Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Wu Han Tongji Hospital

    Wuhan City, Hubei 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Jilin Province Tumor Hospital

    Chang Chun, Ji Lin 130012
    China

    Site Not Available

  • Nan Jing No. 81 Hospital

    Nan Jing, Jiang Su 210002
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Tang Du Hospital, The Second Teaching Hospital of FMMU

    Xi'an, Shanxi 710038
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Chengdu, 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060
    China

    Site Not Available

  • Hospital Umum Sarawak

    Kuching, Sarawak 93586
    Malaysia

    Site Not Available

  • Advanced Medical & Dental Institute HUSM

    Kepala Batas, 13200
    Malaysia

    Site Not Available

  • Advanced Medical & Dental Institute HUSM

    Kepala Batas, Pulau Pinang, 13200
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • National Cancer Institute

    Wilayah Persekutuan, 62250
    Malaysia

    Site Not Available

  • Cebu Doctors Hospital

    Cebu City, Cebu 6000
    Philippines

    Site Not Available

  • St. Luke's Medical Center

    Quezon City, Luzon 1102
    Philippines

    Site Not Available

  • Dr. Pablo O. Torre Memorial Hospital

    Bacolod, 6100
    Philippines

    Site Not Available

  • De La Salle Health Sciences Institute

    Cavite City, 4114
    Philippines

    Site Not Available

  • Rajavithi Hospital

    Bangkok, Ratchathewi District 10400
    Thailand

    Site Not Available

  • King Chulalongkorn Memoiral Hospsital

    Bangkok, 10330
    Thailand

    Site Not Available

  • Police General Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Khon Kaen, 40000
    Thailand

    Site Not Available

  • Khon Kaen Hospital

    Muang, Khon Kaen, 40000
    Thailand

    Site Not Available

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