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

Inclusion Criteria:

- Adult patients (age 18 years or older)

- Pathological diagnosis of soft tissue sarcoma. Pathology materials must be submitted
and reviewed.

- Patients must have unresectable locally advanced or metastatic progressive disease
prior to enrollment. Disease extent must be determined by scans (CT or PET CT)
within 6 weeks of enrollment.

- No prior chemotherapy for soft tissue sarcoma.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ function including the following:

- Adequate bone marrow reserve: absolute neutrophil count (segmented and bands) (ANC)
1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 90 g/L,

- Hepatic: bilirubin 1.5 x the upper limit of normal (ULN), ALT and AST 3.0 x ULN,

- Renal: serum creatinine 1.5 x ULN or calculated creatinine clearance greater than 60
mL/min,

- Cardiac: Left ventricular ejection fraction (LVEF) 50% by echocardiogram (ECHO) or
multiple gated acquisition scan (MUGA);

- All labs must be done within 2 weeks prior to enrollment.

- Negative serum pregnancy test at the time of enrollment for females of childbearing
potential;

- For males and females of child-producing potential, use of effective contraceptive
methods during the study;

- Ability to understand the requirements of the study and provide written informed
consent.

Exclusion Criteria:

- Pregnant or nursing females

- Chest radiotherapy with curative intent to the primary disease complex less than or
equal to 28 days prior to first dose; cranial radiotherapy less than or equal to 21
days prior to first dose; radiotherapy to all other areas less than or equal to 7
days prior to first dose

- Concurrent severe or uncontrolled medical disease (eg, active systemic infection,
diabetes, hypertension, coronary artery disease, congestive heart failure, active
viral hepatitis or chronic liver disease) that, in the opinion of the investigator,
would compromise the safety of the patient or compromise the ability of the patient
to complete the study

- Symptomatic central nervous system metastases. Patients with asymptomatic brain
metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if
the patient is on corticosteroids, the dose of corticosteroids must have been stable
for 2 weeks prior to first dose of study treatment, or be in the process of being
tapered

- Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.

- Patients with known history of seropositive human immunodeficiency virus (HIV) or
patients who are receiving immunosuppressive medications that would, in the opinion
of the investigator, increase the risk of serious neutropenic complications. HIV
testing is not required for inclusion in the trial.

- Known hypersensitivity to any of the components of the i.v. formulation of amrubicin.

- Psychiatric disorder or any other personal circumstances that prevent compliance with
the study protocol.

- Inability or unwillingness to comply with the study protocol.