NCT02235688

Study to Investigate the Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors

An Open-Label Phase 1b Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus gemcitabine in Subjects with solid tumors.

Detailed description

An open-label Phase 1b study to investigate the preliminary safety and activity of aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors administered at doses of 170, 250 or 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	aldoxorubicin	administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
DRUG	aldoxorubicin	administered at 250 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
DRUG	aldoxorubicin	administered at 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
DRUG	gemcitabine

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-09-10
• Last updated: 2022-02-10

Locations

2 sites across 1 country: United States