A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
vorinostat
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vorinostat
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
Secondary Outcome Measures
Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing
Full Information
NCT ID
NCT00127140
First Posted
August 3, 2005
Last Updated
September 25, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00127140
Brief Title
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
Official Title
A Phase I Clinical Study of MK0683 in Patients With Malignant Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vorinostat
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
vorinostat
Primary Outcome Measure Information:
Title
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19817748
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
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