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

• Status: Completed
• Trial end date: 2021-04-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Ramucirumab

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).