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LymphomaPhase 1NCT00771472

Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)

A Phase 1 study testing vorinostat in people with Lymphoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Lymphoma
What is being tested?
vorinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Aug 2008to Jul 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
  • Patients Have Adequate Bone Marrow, Liver Function And Renal Function

Who cannot join

  • Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy
  • Patients Have Uncontrolled Intercurrent Illness
  • Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman

About this study

Official title: Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.

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

    Also called MK-0683, Zolinza

    Parts I \& II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.

Study groups in NCT00771472
Study groupRoleWhat they receive
VorinostatExperimentalNot described
Receives: Drug: vorinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)

    A laboratory AE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.

    Measured: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)

  2. Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

    A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):

    • Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC
    • Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment
    • Grade 4 neutropenia lasting at least 5 days
    • Grade 4 thrombocytopenia
    • Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator
    • Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies

    Measured: Day 1 to Day 28

Secondary outcomes (4)

  1. Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])

    Blood samples taken as follows:

    Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

    Measured: Days 1 & 28 of Cycle 1

  2. Part I: Maximum Drug Concentration (Cmax)

    Blood samples taken as follows:

    Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

    Measured: Days 1 & 28 of Cycle 1

  3. Part I: Time at Which Cmax Occurs (Tmax)

    Blood samples taken as follows:

    Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

    Measured: Days 1 & 28 of Cycle 1

  4. Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)

    Blood samples taken as follows:

    Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

    Measured: Days 1 & 28 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771472
Sponsor's protocol ID
0683-089
Other IDs
2008_565
Status last verified
Apr 2015
First submitted
9 Oct 2008
Last updated
21 Apr 2015
Data monitoring committee
No

Publications

  • Wada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16.

    PubMed 22506596

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 3 inclusion and 3 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 21 Apr 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?

Yes. Results are posted in the registry (first posted 4 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) (time frame: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)). The study lists 2 primary outcomes in all. 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 NCT00771472, 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 21 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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