Clinical trial NCT02898077: A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Keywords: Second line
Angiogenesis
Vascular endothelial growth factor receptor 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)
measure: Overall Survival (OS)
timeFrame: Randomization to Date of Death from Any Cause (Up To 37 Months)
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 Months)
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
timeFrame: Randomization to Objective Disease Progression (Up To 30 Months)
measure: Duration of Objective Response (DoR)
timeFrame: Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)
measure: Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
measure: Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
measure: Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score
timeFrame: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
measure: Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score
timeFrame: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: First hospital affiliated to Zhengzhou University
state: Henan
city: Wuhan City
country: China
facility: Wu Han Tongji Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union (Xiehe) Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Chang Chun
country: China
facility: Jilin Province Tumor Hospital
state: Ji Lin
city: Nan Jing
country: China
facility: Nan Jing No. 81 Hospital
state: Jiang Su
city: Nanjing
country: China
facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Xi'an
country: China
facility: Tang Du Hospital, The Second Teaching Hospital of FMMU
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Kepala Batas, Pulau Pinang
country: Malaysia
facility: Advanced Medical & Dental Institute HUSM
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Wilayah Persekutuan
country: Malaysia
facility: National Cancer Institute
city: Cebu City
country: Philippines
facility: Cebu Doctors Hospital
state: Cebu
city: Bacolod
country: Philippines
facility: Dr. Pablo O. Torre Memorial Hospital
city: Cavite City
country: Philippines
facility: De La Salle Health Sciences Institute
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
state: Ratchathewi District
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memoiral Hospsital
city: Bangkok
country: Thailand
facility: Police General Hospital
city: Muang, Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.