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Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer

2014-08-27 03:34:00 | BioPortfolio

Summary

This study involves Vorinostat (L-001079038), an experimental drug that is believed to work against cancer cells. When cells become cancerous, chemical reactions inside the cancer cells allow those cells to multiply out of control. Vorinostat is designed to affect some of these chemical reactions and to slow the growth of cancer cells. The oral form of Vorinostat has been given to approximately 300 patients with different kinds of cancer. These patients are currently enrolled in ongoing studies as you are in.

The purpose of this study is to test the long-term safety and tolerability of the research study drug, oral Vorinostat , also known as suberoylanilide hydroxamic acid, administered orally in patients with advanced cancers who completed participation in a previous Vorinostat study.

Description

It is standard practice in the development of drugs treating advanced cancer where standard alternative therapy does not exist to continue to offer drug beyond the confines of the parent protocol to patients who are plausibly receiving benefit from it (e.g., those patients who are tolerant of and not progressing on the therapy of the base protocol). Such practice avoids the situation of a responding or potentially responding patient being denied drug after a study of limited duration.

Therefore, this protocol is designed to provide a mechanism for non-progressing patients on L-001079038 protocols to receive drug until disease progression or unacceptable toxicity occurs. There is no significant data capture with regard to safety or efficacy of L-001079038 over the longer treatment period; only SAEs will be captured and reported.

Study Design

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

Conditions

Advanced Cancer

Intervention

L-001079038

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10065

Status

Terminated

Source

Memorial Sloan-Kettering Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:34:00-0400

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