NCT00807859

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

An Open-Label Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Neoplasms
• Breast Tumors
• Cancer
• Locally Recurrent and Metastatic Breast Cancer
• Metastases
• Metastatic Cancer
• Oncology
• Solid Tumors
• Tumors

Interventions

Type	Name	Description
DRUG	AMG 386 30 mg/kg, Paclitaxel and Trastuzumab	AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
DRUG	AMG 386 30 mg/kg, Capecitabine and Lapatinib	AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
DRUG	AMG 386 10 mgkg, Paclitaxel and Trastuzumab	AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
DRUG	AMG 386 10 mg/kg, Capecitabine and Lapatinib	AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD

Timeline

• Start date: 2009-03-09
• Primary completion: 2014-02-27
• Completion: 2015-10-19
• First posted: 2008-12-12
• Last updated: 2022-11-08

Locations

23 sites across 3 countries: United States, Belgium, France