NCT04055753

Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study. Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Doxil	Doxil 50 mg/m2, as per institutional standard
DRUG	Doxorubicin	Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours

Timeline

• Start date: 2016-08-12
• Primary completion: 2026-10-15
• Completion: 2027-10-01
• First posted: 2019-08-14
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States