Gastroesophageal Junction Adenocarcinoma / Gastric Adenocarcinoma
Eli Lilly and Company
The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.
- Drug: RamucirumabAdministered IV
- Drug: PaclitaxelAdministered IV
- Drug: PlaceboAdministered IV
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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.
- 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).
- 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.not yet recruitingBeijing, China, 100021
- 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.recruitingBeijing, China, 100036
- 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.not yet recruitingBeijing, China, 100071
- recruitingChang Chun, China, 130012
- recruitingChangsha, China, 410013
- not yet recruitingChengdu, China, 610041
- recruitingChongqing, China, 400042
- not yet recruitingFuzhou, China, 350001
- recruitingGuangzhou, China, 510060
- not yet recruitingGuangzhou, China, 510080
- recruitingHangzhou, China, 310009
- recruitingHangzhou, China, 310016
- not yet recruitingHarbin, China, 150040
- recruitingNan Jing, China, 210002
- recruitingNanjing, China, 210008
- recruitingNanjing, China, 210009
- recruitingShanghai, China, 200032
- recruitingShenyang, China, 110001
- recruitingTianjin, China, 300060
- recruitingWuhan City, China, 430030
- recruitingWuhan, China, 430022
- not yet recruitingXi'an, China, 710038
- recruitingZhengzhou, China, 450052
- not yet recruitingKepala Batas, Malaysia, 13200
- not yet recruitingKuala Lumpur, Malaysia, 50586
- not yet recruitingKuala Lumpur, Malaysia, 59100
- not yet recruitingKuching, Malaysia, 93586
- not yet recruitingWilayah Persekutuan, Malaysia, 62250
- not yet recruitingBacolod, Philippines, 6100
- not yet recruitingCavite City, Philippines, 4114
- not yet recruitingCebu City, Philippines, 6000
- not yet recruitingQuezon City, Philippines, 1102
- not yet recruitingBangkok, Thailand, 10330
- not yet recruitingBangkok, Thailand, 10400
- not yet recruitingKhon Kaen, Thailand, 4000
01 March, 2017
13 July, 2017