LymphomaPhase 1NCT00127140
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
A Phase 1 study testing vorinostat in people with Lymphoma, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- vorinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Lymphoma
- Being tested
- vorinostat
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat | Experimental | 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. Receives: Drug: vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
Measured: Up to 21 days
Secondary outcomes (1)
Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127140
- Sponsor's protocol ID
- 0683-030
- Other IDs
- 2005_041
- Status last verified
- Sep 2015
- First submitted
- 3 Aug 2005
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19817748
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of MK0683 in Patients With Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT00127140
- Acronym / sponsor ID
- 0683-030
- Conditions
- Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat | Experimental | Drug: vorinostatParticipants 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vorinostat | Drug | Vorinostat |
Primary outcome
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to 21 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Derived from this study: PubMed 19817748Watanabe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vorinostat in people with Lymphoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.