Conditions: Soft Tissue Sarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: All participants who received Amrubicin.

Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Protocol document: