CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Irinotecan +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141034
NCT03141034Phase 2Completed

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

Washington University School of Medicine·interventional·Posted May 4, 2017·Updated Jun 25, 2024

In Brief

A Phase 2 clinical trial evaluating Irinotecan, Ramucirumab, and 2 other interventions for Gastric Adenocarcinoma and Gastro-esophageal Junction Adenocarcinoma. Completed, enrolled 40 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartNov 1, 2017
Primary CompletionApr 14, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.2 years ago

Interventions

Irinotecandrug

-Irinotecan is commercially available and will be billed to insurance.

Ramucirumabdrug

-Ramucirumab will be provided free of charge by Eli Lilly and Company.

Blood for angiome profilinggenetic

-Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment

Blood for cfDNAgenetic

-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