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Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)

NCT03420014 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-10-10

No results posted yet for this study

Summary

The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.

Conditions

  • Leiomyosarcoma

Interventions

DRUG

Doxorubicin

75 mg/m2 doxorubicin will be administered once every 3 weeks (Day 1 of every 21-days cycle).

COMBINATION_PRODUCT

L19TNF plus doxorubicin

13 μg/kg L19TNF will be administered on day 1, 3 and 5 of every 21-days cycle in combination with 60 mg/m2 doxorubicin on day 1 of every 21-days cycle.

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Scott H. Okuno, M.D. · Mayo Clinic, Rochester, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

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 NCT03420014 on ClinicalTrials.gov