Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

This study has been completed.

Study NCT00113334 Information provided by M.D. Anderson Cancer Center

First Received: June 7, 2005 Last Updated: April 24, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Head and Neck Cancer
Intervention:	Drug: ABT-510

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 06/10/05 through 03/02/07. All participants recruited at UT MD Anderson Cancer Center.

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
ABT-510 (Thrombospondin)	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
ABT-510 (Thrombospondin)	No text entered.

Baseline Measures

	ABT-510 (Thrombospondin)
Number of Participants [units: participants]	6
Age [units: years] Mean ( Full Range )	59 ( 43 to 64 )
Gender [units: participants]
Female	2
Male	4
Region of Enrollment [units: participants]
United States	6

Outcome Measures

1. Primary:

Response Rate [ 3 Years ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Response Rate
Measure Description	Protocol responses were as follows: two (2) patients experienced stable disease, three (3) patients were inevaluable for response, and one (1) patient had disease progression.
Time Frame	3 Years
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ABT-510 (Thrombospondin)	No text entered.

Measured Values

	ABT-510 (Thrombospondin)
Number of Participants Analyzed [units: participants]	3
Response Rate [units: participants]
No Change/Stable Disease	2
Progressive Disease	1

No statistical analysis provided for Response Rate

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Edward Kim, MD, BS / Assistant Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6363

No publications provided

Responsible Party:	University of Texas M.D. Anderson Cancer Center ( Edward S. Kim, M.D./Assistant Professor )
Study ID Numbers:	2003-1027
Study First Received:	June 7, 2005
Results First Received:	April 24, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00113334 History of Changes
Health Authority:	United States: Food and Drug Administration