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NCT03141034 · ClinicalTrials.gov registry record · Phase 2
Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03141034: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT03141034 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03141034, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
-PFS will be measured from date of study entry to first radiographic progression or death due to any cause. Radiographic progressive disease (PD) will be defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). For those who are alive and do not experience progression, the investigators will censor them at the time of loss to follow-up or at 30 months from the study entry, whichever comes first.
Interventions
- DRUG Irinotecan
- DRUG Ramucirumab
- GENETIC Blood for angiome profiling
- GENETIC Blood for cfDNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 2 |
What the finished NCT03141034 record still lists
NCT03141034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Irinotecan is the first listed.
NCT03141034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03141034 about?
NCT03141034 is a clinical study titled "Ramucirumab Plus Irinotecan for Previously Treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma". 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...
What is the current status of trial NCT03141034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-11-01. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT03141034?
The interventions under investigation include: Irinotecan (DRUG), Ramucirumab (DRUG), Blood for angiome profiling (GENETIC), Blood for cfDNA (GENETIC).
Who is sponsoring clinical trial NCT03141034?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03141034's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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