Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

This study has been terminated.

(Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00717522

First received: July 16, 2008

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Results First Received: March 6, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Soft Tissue Sarcoma
Intervention:	Drug: Pomalidomide

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
Pomalidomide	7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Participant Flow: Overall Study

	Pomalidomide
STARTED	7
COMPLETED	0
NOT COMPLETED	7
Disease Progression	5
Adverse Event	1
Death	1

Baseline Characteristics

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Reporting Groups

	Description
Pomalidomide	7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Baseline Measures

	Pomalidomide
Number of Participants [units: participants]	7
Age [units: years] Mean ± Standard Deviation	58.9 ± 13.52
Gender [units: participants]
Female	3
Male	4
Race/Ethnicity, Customized [units: participants]
White	7
Non-white	0

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs [ Time Frame: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days). ]

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2. Secondary:

Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines [ Time Frame: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days). ]

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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: Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene’s request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.

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: Associate Director, Clinical Trial Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00717522 History of Changes
Other Study ID Numbers:	CC-4047-STSAR-001
Study First Received:	July 16, 2008
Results First Received:	March 6, 2013
Last Updated:	March 6, 2013
Health Authority:	United States: Food and Drug Administration

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