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A Phase 1 Protocol 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 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.
Details
| Lead sponsor | New Mexico Cancer Research Alliance |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 29 |
| Start date | 2008-07 |
| Completion | 2013-01 |
Conditions
- Lung Cancer
Interventions
- Hydralazine and Valproic Acid: Cohort -1
- Hydralazine and Valproic Acid: Cohort 0
- Hydralazine and Valproic Acid: Cohort 1
- Hydralazine and Valproic Acid: Cohort 2
- Hydralazine and Valproic Acid: Cohort 3
- Hydralazine and Valproic Acid: Cohort 4
- Hydralazine and Valproic Acid: Cohort 5
Primary outcomes
- A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen. — 28 days
Countries
United States