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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907738
First Posted: May 25, 2009
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Advanced Cancer Drug: vorinostat Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.



Enrollment: 27
Study Start Date: August 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorinostat Drug: vorinostat
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 Name: MK-0683

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907738


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00907738     History of Changes
Obsolete Identifiers: NCT00588055
Other Study ID Numbers: 0683-007
2009_595
First Submitted: May 21, 2009
First Posted: May 25, 2009
Results First Submitted: June 14, 2011
Results First Posted: July 14, 2011
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Neoplasms
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action