Maintenance Study on the Long Term Safety of XL999 - Full Text View

Sponsored by:	Symphony Evolution, Inc.
Information provided by:	Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:	NCT00955084

Purpose

The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.

The secondary objectives of this study are as follows:

To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.

Condition	Intervention	Phase
Advanced Malignancies	Drug: XL999	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: XL 999

Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:

The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999. [ Time Frame: Progressive disease or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration [ Time Frame: Progressive disease or end of study ] [ Designated as safety issue: Yes ]

Enrollment:	2
Study Start Date:	August 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL

Eligibility

Criteria

Inclusion Criteria:

The subject is currently enrolled in Protocols XL999-001 or XL999-204
The subject has received XL999 for at least one year prior to enrollment
Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity

Exclusion Criteria:

Progressive disease
Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955084

Locations

United States, Texas

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Symphony Evolution, Inc.

More Information

No publications provided

Responsible Party:	Symphony Evolution, Inc. ( Charles W Finn )
Study ID Numbers:	XL999-900
Study First Received:	August 5, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00955084 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009