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- W2284996855 abstract "3591 Background: XL999 is a potent spectrum-selective inhibitor of tyrosine kinases including VEGFR2/KDR, FGFR1/3, PDGFR-β, FLT3, RET, KIT, & SRC. A Ph 1 study in pts w/advanced malignancies has shown anti-tumor activity (3 PRs &10 SD lasting 3–26 + months) DLTs were cardiac failure & transaminase elevation. Methods: XL999 is being investigated in 6 Ph 2 trials. Pts w/histologically confirmed NSCLC, RCC, CRC, recurrent ovarian CA, AML, & MM were enrolled. The primary objectives of these independent studies are to determine response rate and further evaluate safety and tolerability of XL999. The secondary objectives are to assess PFS, duration of response & OS. Pts receive a once wkly 4hr IV administration of XL999 (2.4 mg/kg). Tumor response is assessed every 8 wks. Results: A total of 79 pts were treated. A confirmed PR was reported in 1/ 9 pts w/NSCLC. An additional 2 pts have SD at 2 & 3 months w/1 showing tumor shrinkage (24%). Two of 11 pts w/RCC have SD at 2 & 4 months. Of 14 pts enrolled w/AML, 1 of 3 with an activating FLT3 mutation had a PR, and 8 of 10 w/circulating myeloblasts had >50% reduction in myeloblasts. AEs = Grade 2 in =10% of pts related to XL999 included N/V, constipation, diarrhea, dry mouth, oral hypoesthesia, fatigue, pyrexia, dizziness, dysguesia, & hypertension. Cardiovascular (CV) events considered SAEs were reported in 11 pts (14%), and all but 1 occurred with the 1st dose of XL999.These events were characterized by ST /T wave changes in ECG,LVEF decreases and /or troponin elevation. Most pts with CV SAEs recovered to baseline within 2–3 wks upon withdrawl of further XL999. Conclusions: XL999 administered IV at a dose of 2.4mg/kg wkly was associated w/CV AEs, the majority of which were associated w/the 1st dose and were generally reversible upon XL999 discontinuation. XL999 shows preliminary evidence of anti- tumor activity in pts w/NSCLC & AML. [Table: see text]" @default.
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- W2284996855 title "Integrated report of the phase 2 experience with XL999 administered IV to patients (pts) with NSCLC, renal cell CA (RCC), metastatic colorectal CA (CRC), recurrent ovarian CA, acute myelogenous leaukemia (AML), and multiple myeloma (MM)" @default.
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