Maintenance Study on the Long Term Safety of XL999
A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
1 other identifier
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedSeptember 24, 2010
September 1, 2010
1.7 years
August 5, 2009
September 23, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Progressive disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hematology Oncology Associates of Rockland Union State Bank Cancer Center
Nyack, New York, 10960, United States
University of Texas Cancer Center
San Antonio, Texas, 78229, United States
Study Officials
- STUDY DIRECTOR
Charles W. Finn, PhD
Symphony Evolution, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 7, 2009
Study Start
August 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
September 24, 2010
Record last verified: 2010-09