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• W2469964205 abstract "e13008 Background: ARQ 197 is a selective, non-ATP competitive inhibitor of c-MET, the exclusive receptor tyrosine kinase for hepatocyte growth factor. Preclinical data suggest combinability of ARQ 197 with gemcitabine. This study aims to evaluate the safety, pharmacokinetics (PK), biomarkers, and preliminary efficacy of the combination in pts with advanced solid tumors. Methods: Multicenter, phase Ib 3+3 dose escalation trial. Oral ARQ 197 is administered at doses of 120-360mg bid across different schedules (continuous vs. continuous with 1 week [wk] break every 2 or 3 wks) in combination with fixed gemcitabine dosing and frequency (1000mg/m2/weekly 3 every 4 wks). Results: 25 metastatic pts (F:M = 13:12; ECOG 0:1 = 12:13; mean age 61, range 44-75 yrs) with mean number of prior systemic treatments = 3.7 (1–9) were treated. No dose-limiting toxicities were observed. Adverse events (AEs) considered at least possibly drug-related were reported in 14 (56%) pts. Most commonly observed (>10%) AEs include neutropenia (10; 40%), thrombocytopenia (6; 24%), anemia (5; 20%), fatigue (4; 16%), leukopenia, nausea, and anorexia (2; 10%). One pt experienced a drug-related serious AE (anemia grade 4). One nonrelated death secondary to hemorrhage occurred on study. Of 16 evaluable pts, 4 pts obtained confirmed partial response by RECIST (ovarian, breast, uterine, NSCLC) and tumor marker decrease (38-83% reduction); 9 pts achieved stable disease (mean duration 15.5, range 8–28+ wks); 4 of these 9 pts had prior progression on gemcitabine (cholangio, ovarian, pancreatic), of whom 3 have now tumor marker decrease (33-80% reduction). PK analysis (patients dosed at 360 mg bid) show a day 1 mean Cmax of 1176 ± 882 ng/mL and AUC(0-12) of 9146 ± 8752 hr*ng/mL. Additional data will be available for presentation. Conclusions: To date, orally administered ARQ 197 in combination with gemcitabine appears well tolerated and without clinically apparent drug-drug interaction or significant exacerbation of known gemcitabine toxicity. Further efficacy is being explored in expanded cohorts for specific tumor types. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration ArQule ArQule" @default.
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• W2469964205 date "2010-05-20" @default.
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• W2469964205 title "Phase Ib dose-escalation trial evaluating c-MET inhibitor ARQ 197 administered in combination with gemcitabine to patients (pts) with advanced solid tumors." @default.
• W2469964205 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e13008" @default.
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