NCT01512199

Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

Randomized, Placebo Controlled, Double Blind Phase 1b/2 Study of U3-1287 (AMG 888) in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed HER2 Positive Metastatic Breast Cancer (MBC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects with metastatic breast cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	U3-1287	U3-1287: 18 mg/kg administered intravenously once every three weeks
DRUG	Trastuzumab	Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
DRUG	Paclitaxel	Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks
DRUG	U3-1287	The maximum tolerated dose as determined in Phase 1b portion (between 9 mg/kg and 18 mg/kg) administered intravenously once every three weeks
DRUG	Trastuzumab	Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
DRUG	Paclitaxel	Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks
DRUG	Placebo	Placebo: Dose corresponding to U3-1287 administered intravenously once every three weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-01-28
• Completion: 2015-01-28
• First posted: 2012-01-19
• Last updated: 2017-10-18

Locations

8 sites across 2 countries: Argentina, Chile