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

This study has been terminated.

Study NCT00486720 Information provided by Merck

First Received on June 14, 2007. Last Updated on May 24, 2010 History of Changes

Results First Received: April 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Myelodysplastic Syndromes Blood Disease Bone Marrow Disease
Intervention:	Drug: vorinostat

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first patient in was 26-Jun-2007. The date of last patient last visit for the study was 16-Jul-2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Vorinostat was studied in patients who were first stratified by their International Prognostic Scoring System for myelodysplastic syndrome (low versus intermediate-1) and than randomized into one of two dose schedules.

Reporting Groups

	Description
Vorinostat Once Daily Dose Schedule	Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
Vorinostat Thrice Daily Dose Schedule	Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.

Participant Flow: Overall Study

	Vorinostat Once Daily Dose Schedule	Vorinostat Thrice Daily Dose Schedule
STARTED	10 ^[1]	12
COMPLETED	0	0
NOT COMPLETED	10	12
Adverse Event	1	2
Lack of Efficacy	4	6
Physician Decision	1	2
Protocol Violation	1	0
Withdrawal by Subject	3	1
Progressive Disease	0	1

[1]	1 randomized patient was discontinued before receiving treatment due to a protocol violation

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Vorinostat Once Daily Dose Schedule	Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
Vorinostat Thrice Daily Dose Schedule	Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.

Baseline Measures

	Vorinostat Once Daily Dose Schedule	Vorinostat Thrice Daily Dose Schedule	Total
Number of Participants [units: participants]	9	12	21
Age [units: years] Mean ± Standard Deviation	69.0 ± 18.5	64.0 ± 10.5	66.0 ± 14.1
Gender [units: participants]
Female	1	5	6
Male	8	7	15
Race/Ethnicity, Customized [units: participants]
White	9	10	19
Black	0	1	1
Asian	0	1	1
Eastern Cooperative Oncology Group (ECOG) Performance Scale Status ^[1] [units: participants]
0 = Normal Activity	4	10	14
1 = Symptoms, but ambulatory	4	1	5
2 = In bed < 50% of the time	1	1	2
International Prognostic Scoring System Risk (IPSS) ^[2] [units: Participants]
Low	3	4	7
Intermediate-1	6	8	14
Prior Myelodysplastic Syndromes Therapy [units: Participants]
Yes	6	3	9
No	3	9	12

[1]	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
[2]	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]

[1]

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

[2]

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]

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria [ Time Frame: 2 Years ]

Show Outcome Measure 1

2. Primary:

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 ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was terminated because the pre-specified futility criterion was met.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00486720 History of Changes
Other Study ID Numbers:	2007_536, MK0683-064
Study First Received:	June 14, 2007
Results First Received:	April 19, 2010
Last Updated:	May 24, 2010
Health Authority:	United States: Food and Drug Administration