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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127140
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

August 3, 2005
August 5, 2005
September 28, 2015
June 2005
April 2012   (Final data collection date for primary outcome measure)
Number of participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]
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Complete list of historical versions of study NCT00127140 on Archive Site
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 ]
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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
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.
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Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: vorinostat
Experimental: Vorinostat
Participants received (Cycle 1) once-daily vorinostat at assigned dose (100 or 200 mg) on Days 1 and 17 and twice-daily on Days 3-16. Thereafter, participants remaining on study received the same dose level therapy twice-daily for 14 consecutive days followed by 7 days of rest.
Intervention: Drug: vorinostat
Watanabe T, Kato H, Kobayashi Y, Yamasaki S, Morita-Hoshi Y, Yokoyama H, Morishima Y, Ricker JL, Otsuki T, Miyagi-Maesima A, Matsuno Y, Tobinai K. Potential efficacy of the oral histone deacetylase inhibitor vorinostat in a phase I trial in follicular and mantle cell lymphoma. Cancer Sci. 2010 Jan;101(1):196-200. doi: 10.1111/j.1349-7006.2009.01360.x. Epub 2009 Sep 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP