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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 is a Phase 2 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 11 participants.
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
Interventions
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01555489
The ClinicalTrials.gov registry entry for NCT01555489 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ascorbic Acid is the first listed.
NCT01555489 reports 0 study locations.
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.
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