A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies
Both
Advanced Malignancies
Trial Information
A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
Progressive disease or end of study
Safety Issue:
Yes
Principal Investigator
Charles W. Finn, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Symphony Evolution, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
XL999-900
NCT ID:
NCT00955084
Start Date:
August 2008
Completion Date:
May 2010
Related Keywords:
- Advanced Malignancies
- Neoplasms
Name | Location |
|---|---|
| Hematology Oncology Associates of Rockland Union State Bank Cancer Center | Nyack, New York 10960 |
| University of Texas Cancer Center | San Antonio, Texas 78229 |
