Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer|
- To evaluate the long-term safety and tolerability of L-001079038 administered orally in patients with advanced cancers. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
All patients will receive open-label study medication at the same dose and schedule as they had been receiving in the base protocol, including any dose modification that was made per the base protocol, until disease progression is documented or the patient develops an unacceptable toxicity. Dose modifications will be made in accordance with the instructions given in the base study.
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Lee Krug, MD||Memorial Sloan-Kettering Cancer Center|
|Study Director:||Stanley Frankel, MD||Merck|