Status:
TERMINATED
Study of XL999 in Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Symphony Evolution, Inc.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell carcinoma (RCC...
Eligibility Criteria
Inclusion
- Males and females with histologically confirmed metastatic clear cell RCC
- Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- No prior systemic cytotoxic chemotherapy
- Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
- ECOG performance status of 0 or 1
- Life expectancy ≥3 months
- Adequate organ and marrow function
- No other malignancies within 5 years
- Signed informed consent
Exclusion
- Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
- Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered \>30 days prior to study enrollment
- History of or known brain metastases, current spinal cord compression or carcinomatous meningitis
- Uncontrolled and/or intercurrent illness
- Pregnant or breastfeeding females
- Known HIV
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00277316
Start Date
December 1 2005
End Date
June 1 2007
Last Update
February 19 2010
Active Locations (9)
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1
Department of Hematology/Oncology
Los Angeles, California, United States, 90095
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
3
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
4
University of Chicago
Chicago, Illinois, United States, 60637