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Use of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies

2014-07-23 21:12:27 | BioPortfolio

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.

Description

This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

Hydralazine and Valproic Acid

Location

University of New Mexico Cancer Center
Albuquerque
New Mexico
United States
87106

Status

Recruiting

Source

New Mexico Cancer Care Alliance

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:27-0400

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