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NCT03193918 · ClinicalTrials.gov registry record · Phase 1
Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma
A Phase 1 study, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03193918: Completed Phase 1 study, sponsored by Arog Pharmaceuticals.
NCT03193918 is a Phase 1 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03193918, a Phase 1 study, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus, GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose expansion phase.
Primary Outcome
The DLT is based on the first cycle (35 days) adverse events. If at least 2 of 3 or 2 of up to 6 patients experience a DLT at the starting dose level, then the study will be paused and the starting dose will be re-assessed. The MTD is defined as the highest dose level in which \<2 of 6 patients develop a DLT. This will constitute the first part of the study which will enroll a maximum of 18 patients.
Interventions
- DRUG Paclitaxel
- DRUG Ramucirumab
- DRUG Crenolanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-04-14 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 1 |
What the finished NCT03193918 record still lists
NCT03193918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.
NCT03193918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03193918 about?
NCT03193918 is a clinical study titled "Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma". This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus, GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose expansion phase.
What is the current status of trial NCT03193918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-04-14. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03193918?
The interventions under investigation include: Paclitaxel (DRUG), Ramucirumab (DRUG), Crenolanib (DRUG).
Who is sponsoring clinical trial NCT03193918?
This trial is sponsored by Arog Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03193918's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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