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NCT00996060 · ClinicalTrials.gov registry record · Phase 1
Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies
A Phase 1 study, sponsored by New Mexico Cancer Research Alliance.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00996060: Completed Phase 1 study, sponsored by New Mexico Cancer Research Alliance.
NCT00996060 is a Phase 1 study that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996060, a Phase 1 study, has completed, sponsored by New Mexico Cancer Research Alliance.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
1. Primary Objective: The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen. 2. Secondary Objectives: The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.
Interventions
- DRUG Hydralazine and Valproic Acid: Cohort -1
- DRUG Hydralazine and Valproic Acid: Cohort 0
- DRUG Hydralazine and Valproic Acid: Cohort 1
- DRUG Hydralazine and Valproic Acid: Cohort 2
- DRUG Hydralazine and Valproic Acid: Cohort 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT00996060 record still lists
NCT00996060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Hydralazine and Valproic Acid: Cohort -1 is the first listed.
NCT00996060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996060 about?
NCT00996060 is a clinical study titled "Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies". 1. Primary Objective: The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is avai...
What is the current status of trial NCT00996060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2008-07. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00996060?
The interventions under investigation include: Hydralazine and Valproic Acid: Cohort -1 (DRUG), Hydralazine and Valproic Acid: Cohort 0 (DRUG), Hydralazine and Valproic Acid: Cohort 1 (DRUG), Hydralazine and Valproic Acid: Cohort 2 (DRUG), Hydralazine and Valproic Acid: Cohort 3 (DRUG).
Who is sponsoring clinical trial NCT00996060?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00996060's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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