Status:
COMPLETED
Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Mesothelioma
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this study is to assess the efficacy and safety of an oral investigational drug suberoylanilide hydroxamic acid (vorinostat, MK-0683) compared to placebo, in the treatment of participants ...
Detailed Description
Treatment Extension Phase: Participants in this study will be eligible to enroll in an open-label treatment extension phase if they: a) were originally randomized to the vorinostat arm and have not ex...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 18 years or older with confirmed diagnosis of malignant pleural mesothelioma
- In countries where pemetrexed is an approved mesothelioma treatment, the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen with pemetrexed and either cisplatin or carboplatin OR in countries where pemetrexed is not approved for mesothelioma, the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen OR pemetrexed is not the preferred therapy for the participant and the participant's disease has progressed or relapsed following treatment with at least one prior chemotherapy regimen
- Received no more than 2 prior systemic therapy regimens
- Karnofsky performance scale status of ≥70
- Has adequate bone marrow, liver, and kidney function and adequate coagulation (per prespecified laboratory values)
- Extension Phase
- Participants who are receiving treatment with vorinostat and have not experienced progression of mesothelioma
- Randomized to the placebo arm and: 1) have a Karnofsky performance scale status of ≥70; and 2) have adequate bone marrow, liver, and kidney function and adequate coagulation (per prespecified laboratory values)
- Randomized to vorinostat and have discontinued study therapy for reasons other than progression of mesothelioma, if the investigator is of the opinion that the potential benefit outweighs potential risks associated with using vorinostat
Exclusion
- Has an active infection for which they received treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug.
- Has a "currently active" second malignancy; a malignancy is not considered "currently active" if participants have completed therapy for the second malignancy and are disease free from prior malignancies for \>5 years
- Has uncontrolled brain metastases
- Has a known human immunodeficiency virus (HIV) infection or HIV-related malignancy
- Is pregnant or breast feeding
- Has a history of gastrointestinal surgery or other procedures that might interfere with the absorption or swallowing of the study drug
Key Trial Info
Start Date :
June 30 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2011
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT00128102
Start Date
June 30 2005
End Date
November 21 2011
Last Update
October 26 2020
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