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NCT01825603 · ClinicalTrials.gov registry record · Phase 1
ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01825603: Completed Phase 1 study, sponsored by University of Nebraska.
NCT01825603 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01825603, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery. ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ADH-1 together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Primary Outcome
The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
Interventions
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Gemcitabine Hydrochloride
- DRUG ADH-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-04-09 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 1 |
What the finished NCT01825603 record still lists
NCT01825603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT01825603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01825603 about?
NCT01825603 is a clinical study titled "ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer". This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other...
What is the current status of trial NCT01825603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-04-09. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT01825603?
The interventions under investigation include: Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Gemcitabine Hydrochloride (DRUG), ADH-1 (DRUG).
Who is sponsoring clinical trial NCT01825603?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01825603's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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