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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Mesothelioma, Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From Day 1 of study treatment to the time of death from any cause

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MK-0683-014

NCT ID:

NCT00128102

Start Date:

June 2005

Completion Date:

November 2011

Related Keywords:

  • Mesothelioma
  • Lung Cancer
  • Advanced malignant pleural mesothelioma
  • Lung Neoplasms
  • Mesothelioma

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