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

Phase 2
18 Years
Not Enrolling
Advanced Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome 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)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

June 2010

Related Keywords:

  • Advanced Cancer
  • Neoplasms