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Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

Saturday, March 1, 2008

This is a Phase III a study which incorporates an initial Phase II component to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural Mesothelioma.

Date First Received: August 5, 2005
Last Updated: April 24, 2008
Verified by: Merck, April 2008
Clinical Trial Phase: Phase 2/Phase 3 | Start
Date: July 2005
Overall Status: Recruiting
Estimated Enrollment: 660

Brief Summary

Official Title: “A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy”

Condition Keyword(s):

• Mesothelioma
• Lung Cancer

Intervention(s):

• Drug: Suberoylanilide Hydroxamic Acid (SAHA)
• Drug: Placebo (unspecified)

This is a Phase III a study which incorporates an initial Phase II component to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural Mesothelioma.

Revised (20-Dec-2007)

Study Type: Interventional

Study Design: Treatment,

Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Outcome Measures for this Clinical Trial

Primary:

• Overall survival and safety/toxicity after 14 consecutive day treatment followed by 7 days of rest repeated in 21 day cycles until disease progression or unacceptable toxicity. Up to 24 weeks of treatment

Secondary:

• Overall objective response, response duration,
  progression-free-survival dyspnea score on LCSS-Meso and
  Forced Vital Capacity change. Treatment will continue
  until disease progression or unacceptable toxicity. Up
  to 24 weeks of treatment

Criteria for
Participation in this Clinical Trial

Inclusion Criteria:

• Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma.
• Patient must have failed prior chemotherapy that included pemetrexed with either cisplatin or carboplatin.
• Patient must have adequate bone marrow, liver and kidney function.
• Patient must be capable of self-care and out of bed for more than 50% of waking hours.
• Patient must have ability to swallow pills.

Exclusion Criteria:

• Patient has been
  treated with other investigational agent that has
  similar properties
• Patient has an active
  infection within 2 weeks of the start of study drug, or
  had treatment with intravenous antibiotic, antiviral, or
  antifungal medications within 2 weeks of the start of
  study drug.
• Patient is pregnant or breast feeding

Clinical Trials Locations, Contact Details, and Sponsors

• Lead Sponsor: Merck
  Call for Information
  Pittsburgh Pennsylvania 15232 United States
• Merck Sharp & Dohme B.V.
  Bruxelles 1180 Belgium
• Msd Sharp & Dohme Gmbh
  Haar 85540 Germany
• Merck Sharp & Dohme B.V.
  Haarlem 2031 BN Netherlands
• Merck Sharp & Dohme (New Zealand) Ltd.,
  Auckland
  New Zealand
• Merck Sharp & Dohme De Espana, S.A.E.
  Madrid 28027 Spain
• Merck Sharp & Dohme (Sweden) AB
  Sollentuna 192 07 Sweden
• Merck Sharp & Dohme Ltd.
  Hoddesdon Hertfordshire EN11 9BU United Kingdom

Overall Clinical Trial Officials and Contacts

• Medical Monitor Study Director Merck
  Overall
  Contact: Toll Free Number 1-888-577-8839
• Additional Information Information obtained from ClinicalTrials.gov on April 29, 2008
• Link to the current ClinicalTrials.gov record.
  http://clinicaltrials.gov/show/NCT00128102
• Study ID Number: 2005_010
• ClinicalTrials.gov Identifier: NCT00128102
• Health Authority: United States: Food and Drug Administration
• (MedWatch – FDA maintained medical product safety Information)
• (PhRMA Clinical Study Results Database – web-based repository for clinical study results)
• (Merck: Patient & Caregiver U.S. Product Web Site)

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial

posted by Your Attorney at 2:05 PM
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