drugset / Trial / NCT01644253

Phase 1b Safety and Efficacy Study of TRU-016

NCT01644253 ↗

Phase 1 Terminated 87 enrolled Aptevo Therapeutics
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.

Timeline

Start
2012-09
Primary completion
2020-02-24
Completion
2021-04-21

Outcome

Outcome not reported

Stopped (Business): “Business decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject Idelalisib Small molecule — —
Subject Obinutuzumab Monoclonal antibody 1000 mg —
Subject Otlertuzumab Monoclonal antibody 10 mg/kg Intravenous
Subject Otlertuzumab Monoclonal antibody 20 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 500 mg/m2 Intravenous
Background Bendamustine Small molecule 90 mg/m2 —
Background Ibrutinib Small molecule — —