Myelodysplastic SyndromesPhase 2NCT00486720

Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)

A Phase 2 study testing vorinostat in people with Myelodysplastic Syndromes and Blood Disease, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease
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: 22 participants
Where: No sites listed yet
Study dates: Jun 2007to Jul 2009
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System
Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
Patient must have adequate organ function

Who cannot join

Patient has clinical evidence of Central Nervous System (CNS) leukemia
Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
Patient had prior treatment with a histone deacetylase inhibitor

About this study

Official title: A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).

Conditions: Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease
Being tested: vorinostat
Medical subject headings: Myelodysplastic Syndromes, Hematologic Diseases, Bone Marrow Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vorinostatDrug
Also called suberoylanilide hydroxamic acid (SAHA), ZOLINZA®
vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.
vorinostatDrug
Also called suberoylanilide hydroxamic acid (SAHA), ZOLINZA®
vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Study groups in NCT00486720
Study group	Role	What they receive
1	Experimental	vorinostat 400 mg Receives: Drug: vorinostat
2	Experimental	vorinostat 200 mg Receives: Drug: vorinostat

What is being measured

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

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.
Measured: 2 Years
Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.
Measured: Every 21 days while on therapy and at 30 days after the last dose of study therapy

Timeline

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

Jun 2007Jul 2009

First posted15 Jun 2007 (estimated)
Study startJun 2007
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Myelodysplastic SyndromesStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486720
Sponsor's protocol ID: 0683-064
Other IDs: MK0683-064, 2007_536
Status last verified: Jun 2015
First submitted: 14 Jun 2007
Last updated: 3 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Myelodysplastic Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT00486720
Acronym / sponsor ID: 0683-064
Conditions: Myelodysplastic Syndromes, Blood Disease, Bone Marrow Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 22 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 15 Jun 2007 (estimated)
Results: Posted 22 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: vorinostatvorinostat 400 mg
2	Experimental	Drug: vorinostatvorinostat 200 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System
Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
Patient must have adequate organ function

Key exclusion criteria (3 listed)

Patient has clinical evidence of Central Nervous System (CNS) leukemia
Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
Patient had prior treatment with a histone deacetylase inhibitor

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
vorinostatAlso: suberoylanilide hydroxamic acid (SAHA), ZOLINZA®vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.	Drug	1
vorinostatAlso: suberoylanilide hydroxamic acid (SAHA), ZOLINZA®vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.	Drug	2

Primary outcome

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
Time frame: 2 Years
Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.
Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.
Time frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy

Results and safety

Results posted to the registry on 22 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vorinostat Once Daily Dose Schedule	10	0
Vorinostat Thrice Daily Dose Schedule	12	0

Primary outcome: Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria

Time frame: 2 Years. Number. Unit: Participants

Measure	Vorinostat Once Daily Dose Schedule n = 9	Vorinostat Thrice Daily Dose Schedule n = 12
Responder	0	0
Non-responder	9	12

Population analysed: Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication.

Primary outcome: Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.

Time frame: Every 21 days while on therapy and at 30 days after the last dose of study therapy. Number. Unit: Participants

Measure	Vorinostat Once Daily Dose Schedule n = 9	Vorinostat Thrice Daily Dose Schedule n = 12
With one or more adverse events	9	12
With no adverse events	0	0
With drug-related adverse events	4	11
With serious adverse events	2	5
With serious drug-related adverse events	0	2

Adverse events

Time frame: Serious and non-serious adverse experiences occurring from the time of consent up through 30 days after the last dose of study drug were reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vorinostat Once Daily Dose Schedule	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Vorinostat Thrice Daily Dose Schedule	5 of 12 (41.7%)	12 of 12 (100%)	Not reported

Limitations and caveats (from the sponsor): This trial was terminated because the pre-specified futility criterion was met.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myelodysplastic Syndromes

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

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 2 study testing vorinostat in people with Myelodysplastic Syndromes and Blood Disease, 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 4 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: stopped early, as of the sponsor's last update on 3 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Jun 2010). 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?

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria (time frame: 2 Years). 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 NCT00486720.

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 3 Jul 2015.