Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.

vorinostat

vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Medical Monitor

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

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

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

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.

Merck Sharp & Dohme LLC

One patient was randomized to the Once Daily Dose Schedule, but discontinued before receiving study medication due to a protocol violation and is not included in the safety assessment.

Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.

Vorinostat Once Daily Dose Schedule

Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.

Vorinostat Thrice Daily Dose Schedule

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian

Race/Ethnicity, Customized

0 = Normal Activity

1 = Symptoms, but ambulatory

2 = In bed < 50% of the time

ECOG Scale: 0 = Normal Activity, 1 = Symptoms, but ambulatory, 2 = In bed \<50% of the time, 3 = In bed \>50% of the time, 4 = 100% Bedridden, 5 = Dead

Eastern Cooperative Oncology Group (ECOG) Performance Scale Status

Intermediate-1

IPSS Risk: Low \[Score = 0; Time to Acute myeloid leukemia (AML) (yrs) = 9.4; Median Survival (yrs) = 5.7\]

IPSS Risk: INT-1 \[Score = 0.5 - 1; Time to AML (yrs) = 3.3; Median Survival (yrs) = 3.5\]

IPSS Risk: INT-2 \[Score = 1.5 - 2; Time to AML (yrs) = 1.1; Median Survival (yrs) = 1.2\]

IPSS Risk: High \[Score = \>2; Time to AML (yrs) = 0.2; Median Survival (yrs) = 0.4\]

International Prognostic Scoring System Risk (IPSS)

Prior Myelodysplastic Syndromes Therapy

This trial was terminated because the pre-specified futility criterion was met.

Senior Vice President, Global Clinical Development

Responder

Non-responder

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.

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

With one or more adverse events

With no adverse events

With drug-related adverse events

With serious adverse events

With serious drug-related adverse events

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

Overall Study

Spots Global Cancer Trial Database for Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial