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NCT02352831 · ClinicalTrials.gov registry record · Phase 1
Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02352831: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT02352831 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02352831, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
There are two parts to this study: the goal of the first part of the study is to find the best dose of tosedostat when given in combination with capecitabine. The goal of the second part of the study is to look at how participants respond to treatment with tosedostat and capecitabine.
Primary Outcome
The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. If 0 or 1 of 6 patients in Dose Level 1 experience DLT during the first cycle, Dose Level 1 will be presumed to be the RP2D. DLTs are followed through completion of the first cycle.
Interventions
- DRUG Capecitabine
- DRUG Tosedostat
- PROCEDURE Fresh tissue biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2018-10-19 |
| Phase | Phase 1 |
Why NCT02352831 stopped before completion
NCT02352831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT02352831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02352831 about?
NCT02352831 is a clinical study titled "Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma". There are two parts to this study: the goal of the first part of the study is to find the best dose of tosedostat when given in combination with capecitabine. The goal of the second part of the study is to look at how participants respond to treatment with tosedostat and capecitabine.
What is the current status of trial NCT02352831?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-08-31. Estimated completion is 2018-10-19.
What interventions are being tested in trial NCT02352831?
The interventions under investigation include: Capecitabine (DRUG), Tosedostat (DRUG), Fresh tissue biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02352831?
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 NCT02352831's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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