Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

Phase 1 Completed 65 enrolled Amgen

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

Timeline

Start: 2009-03-09
Primary completion: 2014-02-27
Completion: 2015-10-19

Publications

Background Kaufman PA, Wildiers H, Freyer G, Kemeny M, Goncalves A, Jerusalem G, Stopeck A, Vrindavanam N, Dalenc F, Nanayakkara N, Wu B, Pickett CA. Phase 1b Study of Trebananib Plus Paclitaxel and Trastuzumab in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):47-57. doi: 10.1016/j.clbc.2018.09.012. Epub 2018 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trebananib	Peptide	10 mg/kg	Intravenous
Subject	Trebananib	Peptide	30 mg/kg	Intravenous
Background	Capecitabine	Small molecule	2000 mg/m2	Oral
Background	Lapatinib	Small molecule	1250 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

Summary

Timeline

Publications

Drugs

Indications