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NCT01555489 · ClinicalTrials.gov registry record · Phase 2
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
A Phase 2 study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01555489: Clinical Trial Phase 2 study, sponsored by Thomas Jefferson University.
NCT01555489 is a Phase 2 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555489, a Phase 2 study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data
Primary Outcome
Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.
Interventions
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
Why NCT01555489 stopped before completion
NCT01555489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Ascorbic Acid is the first listed.
NCT01555489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555489 about?
NCT01555489 is a clinical study titled "Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca". The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given...
What is the current status of trial NCT01555489?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01555489?
The interventions under investigation include: Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT01555489?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01555489's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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