NCT01259375

Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Amrubicin	Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2010-12-14
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

2 sites across 1 country: United States