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). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.
Department of Hematology/Oncology
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 days post last treatment
Progression-free survival
Time frame: Inclusion until disease progression
Duration of response
Time frame: Inclusion until disease progression
Overall survival
Time frame: Inclusion until 180-day Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Time frame: Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.
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University of Chicago
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, United States
Division of Hematology/Oncology, Indiana University Cancer Center
Indianapolis, Indiana, United States
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States