NCT02584309

Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

A Non-Inferiority Study of Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin). In January 2019 Eli Lilly and Company reported that the results of the Phase 3 study of olaratumab (Lartruvo), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Therefore olaratumab is being removed from the front line standard of care regimen. Amendment #9 was made to the protocol to reflect these changes to the standard of care treatment.

Conditions

• Sarcoma, Soft Tissue
• Soft Tissue Sarcoma
• Undifferentiated Pleomorphic Sarcoma
• Leiomyosarcoma
• Liposarcoma
• Synovial Sarcoma
• Myxofibrosarcoma
• Angiosarcoma
• Fibrosarcoma
• Malignant Peripheral Nerve Sheath Tumor
• Epithelioid Sarcoma

Interventions

Type	Name	Description
DRUG	Dexrazoxane
DRUG	Doxorubicin

Timeline

• Start date: 2016-02-22
• Primary completion: 2022-07-17
• Completion: 2022-07-17
• First posted: 2015-10-22
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study