Quantum Leap Healthcare Collaborative

Agent Information Sheet

Widely hailed as the future of phase II drug development, the adaptive I-SPY 2 platform trial has set a new benchmark for
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I-SPY Trial Manuscript
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ganitumab

Trade Name:
AMG-479
Company:
Status:
Stopped for Futility
Agent Chaperone(s):
Treatment Protocol:
Ganitumab is a fully human monoclonal antibody (IgG1). Ganitumab was adminstered at 12 mg/kg by intravenous infusion every 2 weeks (q2w) with Paclitaxel at 80 mg/m2 once a week(q1w) for 12 weeks. This regimen was followed by AC (q2w or q3w) for 4 weeks.
Date Entered I-SPY:
July 9, 2012
Date Left I-SPY:
February 10, 2015
No. Participants in Arm:
122
Graduating Subtypes:
Agent Description:

Ganitumab (AMG-479) is a fully human monoclonal IgG 1 antibody that binds insulin-like growth factor 1 receptor (IGF-I receptor) and is being evaluated in clinical studies as monotherapy and in combination with other agents. The IGF system ganitumab targets has been implicated in the risk of cancer in recent years, including evidence from epidemiological data, research in cancer models and knowledge of the downstream signaling pathways Ras/Raf/extracellular signal-regulated kinase (ERK)/mitogen-activated protein kinase (MAPK) and lipid kinase phosphatidylinositol 3-kinase (PI3K)/AKT, networks which are involved in cell proliferation and survival. As a result, various means of targeting the IGF-I receptor are being explored.

Notes:
Final pCR Probabilities:
Primary Manuscript:
 
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