Journal article
Phase II study of ganitumab, a fully human anti-type-1 insulin-like growth factor receptor antibody, in patients with metastatic ewing family tumors or desmoplastic small round cell tumors
WD Tap, G Demetri, P Barnette, J Desai, P Kavan, R Tozer, PW Benedetto, G Friberg, H Deng, I McCaffery, I Leitch, S Badola, S Chang, M Zhu, A Tolcher
Journal of Clinical Oncology | Published : 2012
Abstract
Purpose: Ganitumab is a fully human monoclonal antibody against type-1 insulin-like growth factor receptor (IGF1R). An open-label phase II study was conducted to evaluate the efficacy and safety of ganitumab monotherapy in patients with metastatic Ewing family tumors (EFT) or desmoplastic small round cell tumors (DSRCT). Patients and Methods: Patients ≥16 years of age with relapsed or refractory EFT or DSRCT received 12 mg/kg of ganitumab every 2 weeks. Objective response rate (ORR) was the primary end point. Secondary end points included clinical benefit rate (CBR = complete + partial responses + stable disease [SD] ≥ 24 weeks) and safety and pharmacokinetic profiles of ganitumab. The relat..
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Funding Acknowledgements
Supported by Amgen.Employment or Leadership Position: Gregory Friberg, Amgen (C); Hongjie Deng, Amgen (C); Ian McCaffery, Amgen (C); Ian Leitch, Amgen (C); Sunita Badola, Amgen (C); Sung Chang, Amgen (C); Min Zhu, Amgen (C) Consultant or Advisory Role: George Demetri, Amgen (C), Novartis (C), Pfizer (C), Ariad (C), Johnson & Johnson (C), PharmaMar (C), Genentech (C), Infinity Pharmaceuticals (C), EMD-Serono (C), GlaxoSmithKline (C), Daiichi-Sankyo (C), ArQule (C); Anthony Tolcher, Abraxis (C), Amgen (C), Exelixis (C), Genentech (C), GlaxoSmithKline (C), Merck (C), Pfizer (C), Biogen Idec (C), Novartis (C), Regeneron Pharmaceuticals (C), Ariad Pharmaceuticals (C), OrthoBiotec (C) Stock Ownership: Pasquale W. Benedetto, Amgen; Gregory Friberg, Amgen; Hongjie Deng, Amgen; Ian McCaffery, Amgen; Ian Leitch, Amgen; Sunita Badola, Amgen; Sung Chang, Amgen; Min Zhu, Amgen Honoraria: George Demetri, Novartis, Pfizer Research Funding: George Demetri, Pfizer, Ariad, Johnson & Johnson, PharmaMar, Infinity Pharmaceuticals, Amgen, Daiichi-Sankyo; Pasquale W. Benedetto, Amgen; Anthony Tolcher, Amgen, Bristol-Myers Squibb, Genentech, Pfizer, OrthoBiotech, Schering-Plough Research Institute, Biogen Idec, ArQule, Bayer, Merck, Novartis, Array BioPharma Expert Testimony: George Demetri, Ariad (U), Johnson & Johnson (U), PharmaMar (U) Other Remuneration: None