A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00632931

First received: February 29, 2008

Last updated: April 21, 2010

Last verified: April 2010

History of Changes

Results First Received: January 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Conditions:	Advanced Cancer Relapsed Advanced Cancer Refractory
Interventions:	Drug: vorinostat Drug: Comparator: placebo (unspecified)

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
All Participants	All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.

Baseline Measures

	All Participants
Number of Participants [units: participants]	25
Age [units: years] Mean ( Full Range )	59.4 ( 29 to 78 )
Gender [units: participants]
Female	12
Male	13
Race/Ethnicity, Customized [units: participants]
Asian	1
Black	2
Hispanic	1
White	21
Cancer Type [units: Participants]
Ovarian	5
Colon	3
Lung	3
Mesothelioma	3
Uterine	2
Soft Tissue	2
Anal	1
Basocellular	1
Breast	1
Gastrointestinal	1
Mucinous carcinoma	1
Pancreatic	1
Thyroid	1
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] [units: Participants]
0 = Normal Activity	9
1 = Symptoms, but ambulatory	13
2 = In bed <50% of the time	3
Number of Prior Radiation Therapies [units: Participants]
None	14
One Prior Radiation Therapy	7
Two Prior Radiation Therapies	1
Three or More Prior Radiation Therapies	3
Number of Prior Systemic Anti-Cancer Therapies [units: Participants]
One Prior Systemic Anti-Cancer Therapy	0
Two Prior Systemic Anti-Cancer Therapies	3
Three or more Prior Systemic Anti-Cancer Therapies	22

[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

Outcome Measures

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1. Primary:

Change From Baseline in QTcF at 0.5 Hours [ Time Frame: Baseline and 0.5 hours ]

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2. Primary:

Change From Baseline in QTcF at 1 Hour [ Time Frame: Baseline and 1 hour ]

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3. Primary:

Change From Baseline in QTcF at 2 Hours [ Time Frame: Baseline and 2 hours ]

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4. Primary:

Change From Baseline in QTcF at 3 Hours [ Time Frame: Baseline and 3 hours ]

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5. Primary:

Change From Baseline in QTcF at 4 Hours [ Time Frame: Baseline and 4 hours ]

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6. Primary:

Change From Baseline in QTcF at 8 Hours [ Time Frame: Baseline and 8 hours ]

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7. Primary:

Change From Baseline in QTcF at 12 Hours [ Time Frame: Baseline and 12 hours ]

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8. Primary:

Change From Baseline in QTcF at 24 Hours [ Time Frame: Baseline and 24 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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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:	NCT00632931 History of Changes
Other Study ID Numbers:	2008_515, MK0683-070
Study First Received:	February 29, 2008
Results First Received:	January 18, 2010
Last Updated:	April 21, 2010
Health Authority:	United States: Food and Drug Administration

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