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 on June 7, 2005. Last Updated on April 24, 2009 History of Changes

Results First Received: April 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
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 [ Time Frame: 3 Years ]

Show Outcome Measure 1

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