NCT01574716

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

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	MORAb-004	IV, Days 1 and 8 of every cycle until disease progression
DRUG	Gemcitabine	IV, Days 1 and 8 of each cycle until disease progression
DRUG	Docetaxel	IV, Day 8 of every cycle until disease progression
DRUG	Gemcitabine	IV, Days 1 and 8 of each cycle until disease progression
DRUG	Docetaxel	IV, Day 8 of every cycle until disease progression
DRUG	Placebo

Timeline

• Start date: 2012-08-07
• Primary completion: 2015-08-11
• Completion: 2016-08-02
• First posted: 2012-04-10
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

29 sites across 6 countries: United States, Australia, Belgium, France, Italy, Netherlands