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Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (0683-014 AM5, EXT1)

Brief Summary

This is a study 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.

Tracking Information
First Received DateAugust 5, 2005
Last Changed DateApril 17, 2015
Start DateJune 2005
Actual Primary Completion DateJuly 2011
Primary Outcome Measures

Overall survival [Time Frame: From Day 1 of study treatment to the time of death from any cause]

Number of participants with adverse events characterized as Grade 3/4 according to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) [Time Frame: From the day of enrollment in the study until 30 days after the last dose of study drug]

Secondary Outcome Measures

Progression-free survival [Time Frame: From Day 1 of study treatment until disease progression or death from any cause]

Objective response rate [Time Frame: Tumor assessments will be performed at baseline and every 42 days from the after the first dose during the first year of treatment and every 84-90 days thereafter]

Percent change from baseline in dyspnea score of the Lung Cancer Symptom Scale modified for mesothelioma (LCSS-Meso) [Time Frame: Baseline and Week 12]

Percent change from baseline in forced vital capacity (FVC) [Time Frame: Baseline and Week 12]

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Mesothelioma
  • Lung Cancer
Intervention
  • Drug: vorinostat
  • Drug: Placebo
Study Arms / Comparison Groups2 / 0
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 experienced disease progression; b) were randomized to the placebo arm and meet the "Extension Phase Inclusion Criteria for Participants in the Placebo Arm" below; or c) were originally randomized to the vorinostat arm and discontinued study therapy for reasons other than progression and the investigator believes that it is in the participant's best interest to resume vorinostat treatment.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment662
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria :

- Participant must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma

- In countries where pemetrexed 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

- Participants must have received no more than 2 prior systemic therapy regimens

- Participant has a Karnofsky performance scale status of ≥70

- Participant must have adequate bone marrow, liver, and kidney function and adequate coagulation (per prespecified laboratory values)

Extension Phase Inclusion Criteria:

- Participants who are receiving treatment with vorinostat and have not experienced progression of mesothelioma

- Participants who were randomized to the placebo arm and are: 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)

- Participants assigned to vorinostat who 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 Criteria :

- Participant has been treated with a Histone deacetylase [HDAC] inhibitor

- Participant 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.

- Participants with 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

- Participant has uncontrolled brain metastases

- Participant has a known human immunodeficiency virus (HIV) infection or HIV-related malignancy

- Participant is pregnant or breast feeding

- Participant has a history of gastrointestinal surgery or other procedures that might interfere with the absorption or swallowing of the study drug

- Participants taking part in the pre-dose spot and post-first dose 24-hour urine collections must exclude medications containing acetominophen or paracetamol for one week prior to the start of vorinostat therapy and during the entire period of urine collection

- Participants taking part in the pre-dose spot and post-first dose 24-hour urine collections may not be using hemodialysis or peritoneal dialysis

Administrative Information
NCTIDNCT00128102
Responsible Party,
SponsorMerck Sharp & Dohme Corp.
Verification DateApril 2015
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