Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor 1.
- A. Tolcher, J. Sarantopoulos, I. Puzanov
- Medicine, BiologyJournal of Clinical Oncology
- 1 December 2009
AMG 479 can be administered safely at 20 mg/kg IV Q2W and the absence of severe toxicities, attainment of serum concentrations associated with high levels of IGF-1R binding on neutrophils, and provocative antitumor activity warrant additional studies of this agent.
Randomized Phase Ib/II Trial of Rilotumumab or Ganitumab with Panitumumab versus Panitumumab Alone in Patients with Wild-type KRAS Metastatic Colorectal Cancer
This is the first study to suggest a benefit for combining an HGF inhibitors with panitumumab in previously treated patients with wild-type KRAS mCRC, and the prespecified criterion for improvement in ORR was met.
Safety, Pharmacokinetics, and Pharmacodynamics of AMG 102, a Fully Human Hepatocyte Growth Factor–Neutralizing Monoclonal Antibody, in a First-in-Human Study of Patients with Advanced Solid Tumors
AMG 102 is safe and well tolerated, has a favorable pharmacokinetic profile, and will be further investigated as a monotherapy and in combination with other agents.
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.
Ganitumab was well tolerated and demonstrated antitumor activity in patients with advanced recurrent EFT or DSRCT and the pharmacokinetic profile of ganitUMab was similar to that observed in the first-in-human trial.
Putative Predictive Biomarkers of Survival in Patients with Metastatic Pancreatic Adenocarcinoma Treated with Gemcitabine and Ganitumab, an IGF1R Inhibitor
Baseline circulating factors of the IGF axis may predict OS benefit from ganitumab plus gemcitabine in metastatic pancreatic adenocarcinoma, and interaction between treatment and IGFs/IGFBPs in multivariate analyses suggested predictive potential for IGF-2 and IGFBP-2.
A Prospective Cohort Study of Mineral Metabolism After Kidney Transplantation
Persistent hyperparathyroidism is common after kidney transplantation and further studies should determine if persistent hyperparathiroidism or its treatment influences long-term posttransplantation clinical outcomes.
Safety and Pharmacokinetics of Ganitumab (AMG 479) Combined with Sorafenib, Panitumumab, Erlotinib, or Gemcitabine in Patients with Advanced Solid Tumors
Ganitumab up to 12 mg/kg was well tolerated, without adverse effects on pharmacokinetics in combination with either sorafenib, panitumumab, erlotinib, or gemcitabine.
AMG 479 in relapsed or refractory Ewing's family tumors (EFT) or desmoplastic small round cell tumors (DSRCT): Phase II results.
This phase II study evaluated the safety and efficacy of AMG 479 in pts with refractory EFT or DSRCT with no previous anti-IGF1R therapy and a futility boundary was developed using a Bayesian approach to stop if either the ORR or clinical benefit rate was unlikely to be ≥ 10%.
A Phase Ib Study of AMG 102 in Combination with Bevacizumab or Motesanib in Patients with Advanced Solid Tumors
AMG 102 in combination with bevacizumab was well tolerated and appeared to have acceptable toxicity, and further evaluation of AMG 102In combination with antiangiogenic agents is warranted.
An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism
This integrated safety assessment of etelcalcetide across placebo- and active-controlled trials showed an overall favorable risk/benefit profile, with safety similar to that of cinacalcet.