Abstract
Background: This phase I study determined the maximum tolerated dose (MTD) of AUY922 with capecitabine in advanced solid tumors. Methods: Capecitabine 1000mg/m2 PO BID was administered with escalating doses of AUY922 IV; the MTD of AUY922 was combined with capecitabine 1250 mg/m2 (DL6). Results: 23 patients were treated at 5 dose levels (22 mg/m2–70 mg/m2). No DLTs were observed until DL6 (grade 3 diarrhea). Reversible vision darkening was seen in 26%. Four patients had partial response; 2 previously progressed on fluorouracil. Eight patients had stable disease (median 25.5 weeks). Conclusion: AUY922 plus capecitabine was well-tolerated up to 70mg/m2 with encouraging preliminary efficacy.
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