A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
2 other identifiers
interventional
440
4 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedStudy Start
First participant enrolled
March 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2021
CompletedResults Posted
Study results publicly available
August 3, 2021
CompletedJune 14, 2022
May 1, 2022
3.3 years
September 8, 2016
June 10, 2021
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)
Overall Survival (OS)
OS defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Randomization to Date of Death from Any Cause (Up To 37 Months)
Secondary Outcomes (7)
Time to Progression (TTP)
Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 Months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Randomization to Objective Disease Progression (Up To 30 Months)
Duration of Objective Response (DoR)
Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)
Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
- +2 more secondary outcomes
Study Arms (2)
8 milligram/kilogram (mg/kg) Ramucirumab + 80 mg/square meter (mg/m²) Paclitaxel
EXPERIMENTAL8 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.
Placebo + 80 mg/m² Paclitaxel
EXPERIMENTALPlacebo 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.
Interventions
Administered IV
Administered IV
Eligibility Criteria
You may qualify if:
- Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 at study entry.
- 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.
You may not qualify if:
- Have undergone major surgery within 28 days prior to randomization.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
First hospital affiliated to Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, 430022, China
Wu Han Tongji Hospital
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nan Jing No. 81 Hospital
Nanjing, Jiangsu, 210002, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, 210008, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jilin Province Tumor Hospital
Changchun, Jilin, 130012, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Tang Du Hospital, The Second Teaching Hospital of FMMU
Xi’an, Shanxi, 710038, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
Beijing Cancer Hospital
Beijing, 100142, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Hospital Umum Sarawak
Kuching, Sarawak, 93586, Malaysia
Advanced Medical & Dental Institute HUSM
Kepala Batas, Pulau Pinang, 13200, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
National Cancer Institute
Wilayah Persekutuan, 62250, Malaysia
Cebu Doctors Hospital
Cebu City, Cebu, 6000, Philippines
Dr. Pablo O. Torre Memorial Hospital
Bacolod, 6100, Philippines
De La Salle Health Sciences Institute
Cavite City, 4114, Philippines
Rajavithi Hospital
Bangkok, Ratchathewi District, 10400, Thailand
King Chulalongkorn Memoiral Hospsital
Bangkok, 10330, Thailand
Police General Hospital
Bangkok, 10330, Thailand
Khon Kaen Hospital
Khon Kaen, 40000, Thailand
Related Publications (1)
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.
PMID: 34626550DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
March 2, 2017
Primary Completion
June 30, 2020
Study Completion
April 12, 2021
Last Updated
June 14, 2022
Results First Posted
August 3, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.