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

Lymphoma Clinical Trial

Official title:

A Phase I Clinical Study of MK0683 in Patients With Malignant Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127140
• Other study ID #: 0683-030
• Secondary ID: 2005_041
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2005
• Last updated: September 25, 2015
• Start date: June 2005
• Est. completion date: April 2012

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• vorinostat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants Experiencing Dose-Limiting Toxicities (DLTs)		Up to 21 days	Yes
Secondary	Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing		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	No