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NCT01900730 · ClinicalTrials.gov registry record · Phase 2
Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01900730: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01900730 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01900730, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if receiving valproic acid (VPA) compared to a placebo can reduce the amount of time you will need to have an indwelling pleural catheter compared to the standard of care, which involves using an indwelling pleural catheter alone. VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer cells to become less malignant and cause less pleural fluid production. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Primary Outcome
Primary outcome is time to pleural catheter removal because it is no longer needed to drain the pleura of fluid. Time to catheter removal measured from the date of placement of the catheter to the date it is removed. Cox (1972) proportional hazards regression used to model time to catheter removal as a function of treatment arm, cytology, and lung re-expansion, as well as other potential prognostic factors, including ECOG performance status, number of circulating tumor cells in peripheral blood
Interventions
- DRUG Placebo
- BEHAVIORAL Questionnaires
- DRUG Valproic Acid (VPA)
- BEHAVIORAL Pill Diary
- BEHAVIORAL Drainage Diary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-07-31 |
| Est. Completion | 2018-06-01 |
| Phase | Phase 2 |
Why NCT01900730 stopped before completion
NCT01900730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01900730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01900730 about?
NCT01900730 is a clinical study titled "Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter". The goal of this clinical research study is to learn if receiving valproic acid (VPA) compared to a placebo can reduce the amount of time you will need to have an indwelling pleural catheter compared to the standard of care, which involves using an indwelling pleural catheter alone. VPA is designed...
What is the current status of trial NCT01900730?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2014-07-31. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT01900730?
The interventions under investigation include: Placebo (DRUG), Questionnaires (BEHAVIORAL), Valproic Acid (VPA) (DRUG), Pill Diary (BEHAVIORAL), Drainage Diary (BEHAVIORAL).
Who is sponsoring clinical trial NCT01900730?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01900730's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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