NCT02235701

Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma

An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.

Conditions

• Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	170 mg/m2 aldoxorubicin	administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
DRUG	250 mg/m2 aldoxorubicin	administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days

Timeline

• Start date: 2014-09-02
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2014-09-10
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

1 site across 1 country: United States