drugset / Trial / NCT01516307

Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

NCT01516307

Phase 2 Completed 349 enrolled OBI Pharma, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.

Timeline

Start
2011-12
Primary completion
2016-08
Completion
2019-08

Drugs

EvaluationDrugModalityDoseRoute
Subject OBI-821 Other / unclassified 100 ug Subcutaneous
Subject adagloxad simolenin Vaccine 30 ug Subcutaneous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Subcutaneous

Indications