drugset / Trial / NCT01574716

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

NCT01574716 ↗

Phase 2 Completed 209 enrolled Morphotek
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

Timeline

Start
2012-08-07
Primary completion
2015-08-11
Completion
2016-08-02

Outcome

Missed primary endpoint

registry p = 0.6562; Hazard Ratio (HR) 1.08 (95% CI 0.77 to 1.50); Log Rank NCT01574716 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ontuxizumab Monoclonal antibody 4 mg/kg Intravenous
Subject Ontuxizumab Monoclonal antibody 6 mg/kg Intravenous
Subject Ontuxizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 900 mg/m2 Intravenous

Indications