2005
DOI: 10.1200/jco.2005.04.192
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Phase I Trial of the Oral Antiangiogenesis Agent AG-013736 in Patients With Advanced Solid Tumors: Pharmacokinetic and Clinical Results

Abstract: In this study, we have demonstrated clinical activity and safety of AG-013736 in patients with advanced solid tumors and identified the dose for phase II testing. The unique phase I study design allowed early identification of important absorption and metabolic issues critical to phase II testing of this agent.

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Cited by 453 publications
(289 citation statements)
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References 36 publications
(5 reference statements)
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“…[46] Hypertension and stomatitis were the main dose-limiting toxicities seen during the phase I study; these were mainly observed with higher doses of axitinib. Other adverse events (AEs) included fatigue, diarrhea, nausea, and vomiting.…”
Section: Axitinib Antitumor Activitymentioning
confidence: 99%
See 1 more Smart Citation
“…[46] Hypertension and stomatitis were the main dose-limiting toxicities seen during the phase I study; these were mainly observed with higher doses of axitinib. Other adverse events (AEs) included fatigue, diarrhea, nausea, and vomiting.…”
Section: Axitinib Antitumor Activitymentioning
confidence: 99%
“…Other adverse events (AEs) included fatigue, diarrhea, nausea, and vomiting. [46] 3. Pharmacokinetics/Pharmacodynamics…”
Section: Axitinib Antitumor Activitymentioning
confidence: 99%
“…The median time to progression was 7.2 months and median overall survival was 18.7 months. A trial testing another multikinase and VEGFR inhibitor, axitinib, is currently underway (Table 2); 1 patient treated with this agent reportedly achieved a partial response that lasted 4 months 76…”
Section: Introductionmentioning
confidence: 99%
“…Drug response was studied across a range of doses based on published data from phase I trials reporting a C max of 72ng/ml and 63ng/ml for sunitinib and axitinib with recommended treatment doses (50mg daily and 5mg twice daily respectively) [169,170]. Minimal responses were seen at 120 …”
Section: Cell Viability Studies In the Presence Of Tkimentioning
confidence: 99%