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Clinical Trials >> 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
Mesothelioma Related Clinical Trials:
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
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Recruiting
Sponsors and Collaborators: Merck
Information provided by: Merck
Government Identifier: NCT00128102
Condition: Mesothelioma; Lung Cancer
Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA); Drug: Placebo (unspecified)
Purpose:
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 |
| 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 |
Further study details as provided by Merck:
Primary Outcome Measures:
- 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. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 660 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental
vorinostat |
Drug: Suberoylanilide Hydroxamic Acid (SAHA)
vorinostat 300 mg b.i.d. capsules twice daily300 mg b.i.d. capsules twice daily Up to 24 weeks of treatment. |
| 2: Placebo Comparator
Placebo |
Drug: Placebo (unspecified)
Pbo capsules twice daily. Up to 24 weeks of treatment. |
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128102Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
| United States, Pennsylvania | |||||
| Call for Information | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15232 | |||||
| Australia | |||||
| Merck Sharp & Dohme (Australia) Pty Ltd. | Recruiting | ||||
| South Granville, Australia, NSW 2142 | |||||
| Contact: David Woolner 64-9523-6075 | |||||
| Chile | |||||
| Merck Sharp & Dohme (I.A.) Corp. | Recruiting | ||||
| Santiago, Chile, 6761641 | |||||
| Contact: Margarita Charlin 562-655-8850 | |||||
| Germany | |||||
| Msd Sharp & Dohme Gmbh | Recruiting | ||||
| Haar, Germany, 85540 | |||||
| Contact: Thomas Lang 49-89-4561-1536 | |||||
| Netherlands | |||||
| Merck Sharp & Dohme B.V. | Recruiting | ||||
| Haarlem, Netherlands, 2031 BN | |||||
| Contact: Gerard Van Leijenhorst 31 23 515 3306 | |||||
| New Zealand | |||||
| Merck Sharp & Dohme (New Zealand) Ltd., | Recruiting | ||||
| Auckland, New Zealand | |||||
| Contact: David Woolner 64-9523-6075 | |||||
| Spain | |||||
| Merck Sharp & Dohme De Espana, S.A.E. | Recruiting | ||||
| Madrid, Spain, 28027 | |||||
| Contact: Jorge Gonzalez-Esteban 34 91 3210726 | |||||
| Sweden | |||||
| Merck Sharp & Dohme (Sweden) AB | Recruiting | ||||
| Sollentuna, Sweden, 192 07 | |||||
| Contact: Roger Juhlin 46-8-626-1 458 | |||||
| United Kingdom, Hertfordshire | |||||
| Merck Sharp & Dohme Ltd. | Recruiting | ||||
| Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU | |||||
| Contact: Paul Robinson 44 1992 452341 | |||||
Sponsors and Collaborators
| Merck |
Investigators
| Study Director: | Medical Monitor | Merck |
Additional Information:
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2005_010, MK0683-014 |
| First Received: | August 5, 2005 |
| Last Updated: | March 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00128102 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
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Study placed in the following topic categories:
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Additional relevant MeSH terms:
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