drugset / Trial / NCT01480583

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

NCT01480583

Phase 2 Completed 85 enrolled Angiochem Inc
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice. In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

Timeline

Start
2011-10
Primary completion
2015-06
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-FLT Diagnostic / imaging agent 185 mbq Intravenous
Subject ANG1005 Peptide 550 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous