MedTrace Logo

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

NCT02584309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2023-11-07

Study results available
· View outcomes & findings →

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

DRUG

Dexrazoxane

DRUG

Doxorubicin

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Brian A Van Tine, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2022-07-17
Completion
2022-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02584309 on ClinicalTrials.gov