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NCT01231399 · ClinicalTrials.gov registry record · Phase 1
Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01231399: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT01231399 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231399, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with combination chemotherapy in treating patients with metastatic stomach or esophageal cancer that has spread to other places in the body.
Primary Outcome
The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Interventions
- OTHER laboratory biomarker analysis
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT01231399 record still lists
NCT01231399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01231399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01231399 about?
NCT01231399 is a clinical study titled "Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer". RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping t...
What is the current status of trial NCT01231399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-02. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01231399?
The interventions under investigation include: laboratory biomarker analysis (OTHER), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), everolimus (DRUG).
Who is sponsoring clinical trial NCT01231399?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01231399's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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