Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dendreon

ClinicalTrials.gov Identifier:

NCT00849290

First received: February 19, 2009

Last updated: March 12, 2013

Last verified: March 2013

History of Changes

Results First Received: May 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metastatic Androgen Independent Prostate Cancer
Intervention:	Biological: APC8015F

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
Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had objective disease progression on Dendreon’s Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

Reporting Groups

	Description
APC8015F	APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.

Participant Flow: Overall Study

	APC8015F
STARTED	113
COMPLETED	58
NOT COMPLETED	55
Adverse Event	3
Death	14
Withdrawal by Subject	11
Lost to Follow-up	2
Protocol Violation	5
Disease Progression	20

Baseline Characteristics

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Reporting Groups

	Description
APC8015F	No text entered.

Baseline Measures

	APC8015F
Number of Participants [units: participants]	113
Age [units: years] Mean ( Full Range )	70.0 ( 40 to 87 )
Gender [units: participants]
Female	0
Male	113

Outcome Measures

1. Primary:

Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ]

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2. Secondary:

To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.

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
No text entered.

Results Point of Contact:

Name/Title: Kathleen Picha
Organization: Dendreon Corporation
phone: 206-274-6762
e-mail: kpicha@dendreon.com

No publications provided

Responsible Party:	Dendreon
ClinicalTrials.gov Identifier:	NCT00849290 History of Changes
Obsolete Identifiers:	NCT00090922, NCT00170066, NCT00513006
Other Study ID Numbers:	PB01
Study First Received:	February 19, 2009
Results First Received:	May 28, 2010
Last Updated:	March 12, 2013
Health Authority:	United States: Food and Drug Administration

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