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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:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00907738
First received: May 21, 2009
Last updated: June 14, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907738

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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00907738     History of Changes
Obsolete Identifiers: NCT00588055
Other Study ID Numbers: MK-0683-007, 2009_595
Study First Received: May 21, 2009
Results First Received: June 14, 2011
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014