Authors
Cristiana Sessa, Geoffrey I Shapiro, Kapil N Bhalla, Carolyn Britten, Karen S Jacks, Monica Mita, Vali Papadimitrakopoulou, Tim Pluard, Thomas A Samuel, Mikhail Akimov, Cornelia Quadt, Cristina Fernandez-Ibarra, Hong Lu, Stuart Bailey, Sandra Chica, Udai Banerji
Publication date
2013/7/1
Journal
Clinical Cancer Research
Volume
19
Issue
13
Pages
3671-3680
Publisher
American Association for Cancer Research
Description
Purpose: A phase I study was conducted with the primary objective of determining the maximum tolerated dose (MTD) of AUY922 in patients with advanced solid tumors. Secondary objectives included characterization of the safety, pharmacokinetic, and pharmacodynamic profiles.
Patients and Methods: Patients with advanced solid tumors received 1-hour i.v. infusions of AUY922 once a week in a 28-day cycle. An adaptive Bayesian logistic regression model that employed observed dose-limiting toxicities (DLT) in the first treatment cycle was used to guide dose-escalation decisions, with the established MTD to be used in phase II studies.
Results: One hundred and one patients were enrolled and explored at doses in the range of 2 to 70 mg/m2. DLTs occurred in 8 patients (22–70 mg/m2) and included diarrhea, asthenia/fatigue, anorexia, atrial flutter, and visual symptoms. At 70 mg …
Scholar articles
C Sessa, GI Shapiro, KN Bhalla, C Britten, KS Jacks… - Clinical Cancer Research, 2013