A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)

Merck Sharp & Dohme LLC10 enrolled

Overview

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

vorinostatDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy Exclusion Criteria: * Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody) * Any uncontrolled concomitant illness * Are pregnant or breast-feeding * Serious drug or food allergy

Outcomes

Primary Outcomes

Number of participants Experiencing Dose-Limiting Toxicities (DLTs)

Time frame: Up to 21 days

Secondary Outcomes

Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose on Days 1 and 17

Data from ClinicalTrials.gov

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