Lymphoma, T-Cell, CutaneousNCT00419367
Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)
A study testing Comparator: vorinostat in people with Lymphoma, T-Cell, Cutaneous, run by Merck Sharp & Dohme LLC.
Trial summary
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- Comparator: vorinostat
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced cutaneous T-cell lymphoma on or following two systemic therapies
- Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
- Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
- Male participants must agree to use 2 adequate barrier methods of contraception
- To be treated on extension phase of study participant must have been treated on the base study for Protocol 042
Who cannot join
- Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
- Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
- Pregnant or lactating
- Known allergy to any component of the study drug
- Eligible for any other study of vorinostat in CTCL patients
About this study
Official title: Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and
continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.
The extension phase will begin as soon as the protocol amendment is implemented.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- Comparator: vorinostat
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: vorinostatDrug
Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, CutaneousStudies 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
- Expanded access
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
- NCT00419367
- Sponsor's protocol ID
- 0683-042
- Other IDs
- MK0683-042, 2006_540, 2006-003879-12
- Status last verified
- Sep 2022
- First submitted
- 5 Jan 2007
- Last updated
- 22 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00419367
- Acronym / sponsor ID
- 0683-042
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- First posted
- 8 Jan 2007 (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.
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and
continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.
The extension phase will begin as soon as the protocol amendment is implemented.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced cutaneous T-cell lymphoma on or following two systemic therapies
- Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
- Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
- Male participants must agree to use 2 adequate barrier methods of contraception
- To be treated on extension phase of study participant must have been treated on the base study for Protocol 042
Key exclusion criteria (5 listed)
- Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
- Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
- Pregnant or lactating
- Known allergy to any component of the study drug
- Eligible for any other study of vorinostat in CTCL patients
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 |
|---|---|---|
| Comparator: vorinostatEach patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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 study testing Comparator: vorinostat in people with Lymphoma, T-Cell, Cutaneous, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 22 Sep 2022.