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

NCT04055753 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2026-05-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-12
Primary Completion
2026-10-15
Completion
2027-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055753 on ClinicalTrials.gov