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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127140

Enrollment

Registered

2005-08-05

Start date

2005-06-30

Completion date

2012-04-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Brief 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.

Interventions

DRUGvorinostat

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)	Up to 21 days

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026