A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors

Phase 1 Completed 18 enrolled Takeda

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.

Timeline

Start: 2009-06
Primary completion: 2014-05
Completion: 2014-05

Publications

Results Doi T, Ohtsu A, Fuse N, Yoshino T, Tahara M, Shibayama K, Takubo T, Weinreich DM. Phase 1 study of trebananib (AMG 386), an angiogenesis targeting angiopoietin-1/2 antagonist, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Jan;71(1):227-35. doi: 10.1007/s00280-012-2000-1. Epub 2012 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trebananib	Peptide	3 mg/kg	Intravenous
Subject	Trebananib	Peptide	10 mg/kg	Intravenous
Subject	Trebananib	Peptide	30 mg/kg	Intravenous

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications