Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Merck
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588055

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.

Condition	Intervention
Advanced Cancer	Drug: L-001079038

MedlinePlus related topics: Cancer

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Continuation Clinical Trial of Oral L-0010790038 in Advanced Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: L-001079038 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.

Arms

Assigned Interventions

1: Experimental

Drug: L-001079038

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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588055

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Merck

Investigators

Principal Investigator:	Lee Krug, MD	Memorial Sloan-Kettering Cancer Center
Study Director:	Stanley Frankel, MD	Merck

More Information

Additional Information:

Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co ( Stanley Frankel, M.D. )
Study ID Numbers:	05-072, 007-00
Study First Received:	December 26, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00588055 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Cancer
Advanced Cancer
L-001079038
SAHA
Vorinostat

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Vorinostat

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vorinostat
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009