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Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma — ARSARC-PI-0010  

Soft Tissue Sarcoma Clinical Trial

Official title:
A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Clinical Trial Summary

Primary Objectives

1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy.

2. To evaluate Progression Free Survival (PFS).

Secondary Objectives

1. To assess the safety and tolerability of amrubicin in this patient population.

2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential response to amrubicin.

3. To investigate quality of response with radiographic evaluation using both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.

4. To evaluate overall survival (OS).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01259375
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date February 2016
View Details
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