drugset / Trial / NCT01997333

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

NCT01997333 ↗

Phase 2 Completed 327 enrolled Celldex Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

Timeline

Start
2013-11
Primary completion
2017-11-30
Completion
2018-08-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Capecitabine vs CDX-011; p = 0.761; Log Rank NCT01997333 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule — —
Subject Glembatumumab Vedotin Other / unclassified — Intravenous