A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
Patient did not withdraw from the base protocol
Patient agrees to practice effective birth control during the study

Exclusion criteria

Patient is receiving other standard and/or investigational anticancer therapy
Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug

Treatment and study plan

Vorinostat

Drug

All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.

Other names: MK-0683

Primary outcomes

Percent of Participants With a Serious Drug-related Adverse Event (AE)

Time frame: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)

A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.

A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: May 25, 2009
Registry last updated: May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed