NCT02049905

Phase 3 Study to Treat Patients With Soft Tissue Sarcomas

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

Conditions

• Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Aldoxorubicin
DRUG	Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-01-30
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

74 sites across 13 countries: United States, Australia, Canada, Chile, Denmark, France, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain