Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

This study has been terminated.

( According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. )

Study NCT00638378 Information provided by Incyte Corporation

First Received on March 12, 2008. Last Updated on January 20, 2012 History of Changes

Results First Received: December 15, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metastatic Prostate Cancer
Intervention:	Drug: Ruxolitinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ruxolitinib	Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.

Participant Flow: Overall Study

	Ruxolitinib
STARTED	22
COMPLETED	0
NOT COMPLETED	22
Death	2
Adverse Event	1
Disease progression	15
Physician Decision	4

Baseline Characteristics

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Reporting Groups

	Description
Ruxolitinib	Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.

Baseline Measures

	Ruxolitinib
Number of Participants [units: participants]	22
Age [units: years] Mean ± Standard Deviation	70.4 ± 7.11
Gender [units: participants]
Female	0
Male	22

Outcome Measures

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1. Primary:

Number of Participants With a Prostate-specific Antigen Response [ Time Frame: Assessed monthly from Baseline until the end of study (up to 8 months) ]

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2. Primary:

Number of Participants With Adverse Events (AE) [ Time Frame: From Baseline through to the end of study (up to 8 months) ]

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3. Secondary:

Time to Progression [ Time Frame: From Baseline until the end of study (up to 8 months). ]

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4. Secondary:

Number of Participants With a Complete Response or Partial Response [ Time Frame: From Baseline through the end of study (up to 8 months) ]

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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: Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.

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: Study Director
Organization: Incyte Corporation
phone: 1-855-463-3463

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00638378 History of Changes
Other Study ID Numbers:	INCB 18424-254
Study First Received:	March 12, 2008
Results First Received:	December 15, 2011
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration