Maintenance Study on the Long Term Safety of XL999

Phase 1

Completed

• Conditions: Advanced Malignancies

• Registration Number: NCT00955084
• Lead Sponsor: Symphony Evolution, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Progressive disease or end of study

Secondary Outcome Measures

Name	Time	Method
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	Progressive disease or end of study

Trial Locations

Locations (2)

Hematology Oncology Associates of Rockland Union State Bank Cancer Center; 🇺🇸 Nyack, New York, United States

University of Texas Cancer Center; 🇺🇸 San Antonio, Texas, United States