Viewing Study NCT00128102



Ignite Creation Date: 2024-05-05 @ 11:46 AM
Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00128102
Status: COMPLETED
Last Update Posted: 2020-10-26
First Post: 2005-08-05

Brief Title: Suberoylanilide Hydroxamic Acid Vorinostat MK-0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma MK-0683-014
Sponsor: Merck Sharp Dohme LLC
Organization: Merck Sharp Dohme LLC

Study Overview

Official Title: A Phase III Randomized Double-Blind Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid Vorinostat MK-0683 in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 with advanced malignant pleural mesothelioma who have failed at least one prior chemotherapy regimen The primary hypotheses are the following 1 vorinostat improves overall survival OS compared to placebo 2 vorinostat is generally safe and well tolerated
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 participants best interest to resume vorinostat treatment

As specified by the protocol based on planned extension phase inclusion criteria and pre-specified primary outcome analyses requirements the extension phase of this study was not conducted

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
MK-0683-014 OTHER Merck None
2005_010 OTHER None None
CTRI2009091000146 REGISTRY None None