Expired Study
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New York, New York 10065


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: - Patient has completed participation in one of the Suberoylanilide Hydroxamic Acid (SAHA) protocols, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities. - Patient has not met criteria for withdrawal from the base protocol. - Patient is willing to comply with protocol requirements and procedures, and keep scheduled study visits. - Patient agrees to practice effective contraception during the entire study period unless documentation of infertility exists. - Patient is able to understand and is willing to sign the informed consent form. Exclusion Criteria: - Patient is receiving concomitant standard and/or investigational anticancer therapy. Local palliative radiotherapy is permissible upon discussion with the Merck Clinical Monitor. - Patient has alcohol or substance abuse which in the opinion of the investigator would interfere with compliance or safety. - Patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient.


NCT ID:

NCT00588055


Primary Contact:

Principal Investigator
Lee Krug, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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