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

NCT03141034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-25

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Kian-Huat Lim, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2023-04-14
Completion
2023-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141034 on ClinicalTrials.gov