NCT03420014

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

A Randomized Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Metastatic Leiomyosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for metastatic leiomyosarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.

Conditions

• Leiomyosarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-27
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2018-02-05
• Last updated: 2023-10-10

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study