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
Close
Close
I-SPY Trial Manuscript
<- Back to All Agents

trebananib

Trade Name:
amg 386
Company:
Status:
Stopped for Futility
Agent Chaperone(s):
Treatment Protocol:
AMG 386 is a Angiogenesis/Angiopoietin Inhibitor. For HER 2- patients, AMG 386 was administered at 15 mg/kg once a week (q1w), with trastuzumab at a 4 mg/kg (loading dose) and 2 mg/kg (thereafter) by intravenous infusion, and paclitaxel at 80 mg/m2 once a week (q1w) for 12 weeks. This was followed by AC (q2w or q3w) for 4 weeks. For HER 2+ patients, AMG 386 was administered once a week at 15 mg/kg (q1w) by intravenous infusion with paclitaxel at 80 mg/m2 once a week (q1w) for 12 weeks. This was followed by AC (q2w or q3w) for 4 weeks.
Date Entered I-SPY:
October 12, 2011
Date Left I-SPY:
July 22, 2014
No. Participants in Arm:
134
Graduating Subtypes:
Agent Description:

Trebananib (AMG 386) is an angiopoietin (Ang) 1 and 2 neutralizing peptibody that targets and binds to Ang1 and Ang2, thereby preventing the interaction of the angiopoietins with their target tie2 receptors. This may inhibit angiogenesis and may eventually lead to an inhibition of tumor cell proliferation.

Notes:

Accrual was stopped when the maximum sample size was reached. Predicted probabilities of success in a phase II trial was highest in the HR- signature, at 78.4%, short of the 85% threshold for graduation. There was some evidence of improved efficacy in HR-, MP+, HR-/HER2- and HER-/HER2+ tumors, with increased rates of pCR in the experimental arm, but not reaching statistical significance.

Final pCR Probabilities:
Primary Manuscript:
 
abstractpdfdoi link