NCT03141034

Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

Ramucirumab Plus Irinotecan in Patients With Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab administered as second line treatment will be tolerated and lead to improved outcomes similar to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have progressed after first line chemotherapy. To the knowledge of the investigators, this regimen has not been previously administered to this patient population, so safety and tolerability will be monitored and reported.

Conditions

• Gastric Adenocarcinoma
• Gastro-esophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Irinotecan	-Irinotecan is commercially available and will be billed to insurance.
DRUG	Ramucirumab	-Ramucirumab will be provided free of charge by Eli Lilly and Company.
GENETIC	Blood for angiome profiling	-Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
GENETIC	Blood for cfDNA	-Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment

Timeline

• Start date: 2017-11-01
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2017-05-04
• Last updated: 2024-06-25
• Results posted: 2024-06-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study