drugset / Trial / NCT01338831

Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

NCT01338831 ↗

Phase 1 Completed 73 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.

Timeline

Start
2011-09
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject LFA102 Monoclonal antibody 3 mg/kg Intravenous
Subject LFA102 Monoclonal antibody 60 mg/kg Intravenous