Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer

Condition(s) targeted: Advanced Cancer

Intervention: L-001079038 (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Lee Krug, MD, Principal Investigator, Affiliation: Memorial Sloan-Kettering Cancer Center
Stanley Frankel, MD, Study Director, Affiliation: Merck

Overall contact:
Lee Krug, MD, Email: krugl@mskcc.org

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.

Official title: Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer

Study design: Treatment, Open Label, Single Group Assignment, Safety Study

Primary outcome: To evaluate the long-term safety and tolerability of L-001079038 administered orally in patients with advanced cancers.

Detailed 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Lee Krug, MD, Email: krugl@mskcc.org

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Lee Krug, MD, Email: krugl@mskcc.org

Memorial Sloan-Kettering web site

Starting date: August 2005
Ending date: August 2010
Last updated: June 19, 2008