drugset / Trial / NCT00996060

Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies

NCT00996060

Phase 1 Completed 29 enrolled New Mexico Cancer Research Alliance
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-07
Primary completion
2012-12
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydralazine Small molecule 10 mg Oral
Subject Hydralazine Small molecule 25 mg Oral
Subject Hydralazine Small molecule 50 mg Oral
Subject Hydralazine Small molecule 100 mg Oral
Subject Hydralazine Small molecule 200 mg Oral
Subject Hydralazine Small molecule 300 mg Oral
Subject Hydralazine Small molecule 400 mg Oral
Subject Valproic Acid Small molecule 500 mg Oral

Indications