A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
NCT ID: NCT02898077
Last Updated: 2022-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
440 participants
INTERVENTIONAL
2017-03-02
2021-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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8 milligram/kilogram (mg/kg) Ramucirumab + 80 mg/square meter (mg/m²) Paclitaxel
8 mg/kg ramucirumab was administered as an intravenous infusion (IV) on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle.
Participants may continue on treatment until discontinuation criteria were met.
Ramucirumab
Administered IV
Paclitaxel
Administered IV
Placebo + 80 mg/m² Paclitaxel
Placebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle.
Participants may continue on treatment until discontinuation criteria were met.
Paclitaxel
Administered IV
Placebo
Administered IV
Interventions
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Ramucirumab
Administered IV
Paclitaxel
Administered IV
Placebo
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma.
* Have metastatic disease or locally advanced, unresectable disease.
* Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
* Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease.
* Have adequate organ function.
* Have urinary protein ≤1+ on dipstick or routine urinalysis.
Exclusion Criteria
* Have received any first-line chemotherapy other than platinum and fluoropyrimidine with 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 signaling pathways.
* Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization.
* Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry.
* Have a history of GI perforation and/or fistulae within 6 months prior to randomization.
* Have experienced any arterial thromboembolic event within 6 months prior to randomization.
* Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of mercury \[mmHg\] or diastolic blood pressure ≥100 mmHg) despite standard medical management.
* Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
* Have a serious illness or medical condition(s).
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
First hospital affiliated to Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, China
Wu Han Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nan Jing No. 81 Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jilin Province Tumor Hospital
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tang Du Hospital, The Second Teaching Hospital of FMMU
Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Advanced Medical & Dental Institute HUSM
Kepala Batas, Pulau Pinang, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
National Cancer Institute
Wilayah Persekutuan, , Malaysia
Cebu Doctors Hospital
Cebu City, Cebu, Philippines
Dr. Pablo O. Torre Memorial Hospital
Bacolod, , Philippines
De La Salle Health Sciences Institute
Cavite City, , Philippines
Rajavithi Hospital
Bangkok, Ratchathewi District, Thailand
King Chulalongkorn Memoiral Hospsital
Bangkok, , Thailand
Police General Hospital
Bangkok, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Countries
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References
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Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, Qin Y, Qin S, Yin X, Liu B, Ba Y, Yang N, Voon PJ, Tanasanvimon S, Zhou C, Zhang WL, Shen L. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7. Epub 2021 Oct 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I4T-CR-JVCR
Identifier Type: OTHER
Identifier Source: secondary_id
15244
Identifier Type: -
Identifier Source: org_study_id
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