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
2 other identifiers
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lymphoma
Started Jun 2005
Longer than P75 for phase_1 lymphoma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 28, 2015
September 1, 2015
6.8 years
August 3, 2005
September 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
Up to 21 days
Secondary Outcomes (1)
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
Study Arms (1)
Vorinostat
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19817748DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2005
First Posted
August 5, 2005
Study Start
June 1, 2005
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 28, 2015
Record last verified: 2015-09