This clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of XL999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. 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
24
Treatment was administered on an outpatient basis. XL999 was administered at 2.4 mg/kg as a 4 hour intravenous (IV) infusion. Subjects received a XL999 infusion once a week for 8 weeks of treatment unless drug-related toxicity required a dosing delay
California Cancer Care, Inc.
Greenbrae, California, United States
Hematology/Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
University of Chicago
Chicago, Illinois, 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 after last treatment or death
Pharmacokinetic (PK) and pharmacodynamics (PD) parameters
Time frame: Samples will be collected pre-dose and immediatelyat the end of infusion for the 8-week Study Treatment Period for subjects in the second stage of the study
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Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Bradley Cohen
New City, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States