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NCT02138929 · ClinicalTrials.gov registry record · Phase 1
LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02138929: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02138929 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138929, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of LDE225 that can be given in combination with everolimus to patients with esophageal or GEJ cancer. The safety of the drug combination will also be studied.
Primary Outcome
Maximum tolerated dose (MTD) defined as highest dose level for the combination therapy with no more than 1 out of 6 patients experiencing dose limiting toxicity (DLT). DLT defined as an adverse event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤56 days following the first dose of LDE225 (DLT assessment period).
Interventions
- DRUG Everolimus
- DRUG LDE 225
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-11-10 |
| Est. Completion | 2020-06-08 |
| Phase | Phase 1 |
What the finished NCT02138929 record still lists
NCT02138929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT02138929 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02138929 about?
NCT02138929 is a clinical study titled "LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma". The goal of this clinical research study is to find the highest tolerable dose of LDE225 that can be given in combination with everolimus to patients with esophageal or GEJ cancer. The safety of the drug combination will also be studied.
What is the current status of trial NCT02138929?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-11-10. Estimated completion is 2020-06-08.
What interventions are being tested in trial NCT02138929?
The interventions under investigation include: Everolimus (DRUG), LDE 225 (DRUG).
Who is sponsoring clinical trial NCT02138929?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02138929's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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