Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

Inclusion Criteria:

   - Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female.

   - Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor
   recurrence for at least 12 months since the last measurement, beginning or end of last
   chemotherapy.

   - Histologically or cytologically confirmed, locally advanced, unresectable, and/or
   metastatic soft tissue sarcoma of intermediate or high grade.

   - Capable of providing informed consent and complying with trial procedures.

   - ECOG performance status 0-2.

   - Life expectancy > 12 weeks.

   - Measurable tumor lesions according to RECIST 1.1 criteria.

   - Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,
   surgically sterile, or practicing adequate birth control methods) for the duration of
   the study. (Adequate contraception includes: oral contraception, implanted
   contraception, intrauterine device implanted for at least 3 months, or barrier method
   in conjunction with spermicide.)

   - Women of child bearing potential must have a negative serum or urine pregnancy test at
   the Screening Visit and be non-lactating.

   - Geographic accessibility to the site that ensures the subject will be able to keep all
   study-related appointments.

Exclusion Criteria:

   - Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence
   for at least 12 months.

   - Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.

   - Palliative surgery and/or radiation treatment less than 4 weeks prior to
   Randomization.

   - Exposure to any investigational agent within 30 days of Randomization.

   - Current Stage 1 or 2 soft tissue sarcomas.

   - Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma,
   rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST),
   dermatofibrosarcoma, Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear
   cell sarcomas and unresectable low grade liposarcomas.

   - Central nervous system metastasis

   - History of other malignancies except cured basal cell carcinoma, superficial bladder
   cancer or carcinoma in situ of the cervix unless documented free of cancer for > 5
   years.

   - Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN),
   alanine aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present,
   total bilirubin > 3 × ULN, absolute neutrophil count < 1,500/mm3, platelet
   concentration < 100,000/mm3, hematocrit level < 25% for females or < 27% for males, or
   coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT],
   International Normalized Ratio [INR]) > 1.5 × ULN, albumin < 2.0 g/dL.

   - Clinically evident congestive heart failure > class II of the New York Heart
   Association (NYHA) guidelines.

   - Current, serious, clinically significant cardiac arrhythmias, defined as the existence
   of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

   - Baseline QTc > 470 msec and/or previous history of QT prolongation while taking other
   medications. Concomitant use of medications associated with a high incidence of QT
   prolongation is not allowed.

   - History or signs of active coronary artery disease with or without angina pectoris.

   - Serious myocardial dysfunction defined as scintigraphically (e.g. MUGA, myocardial
   scintigram) or ultrasound determined absolute left ventricular ejection fraction
   (LVEF) < 45% of predicted.

   - History of HIV infection.

   - Active, clinically significant serious infection requiring treatment with antibiotics,
   anti-virals or anti-fungals.

   - Major surgery within 3 weeks prior to Randomization.

   - Substance abuse or any condition that might interfere with the subject's participation
   in the study or in the evaluation of the study results.

   - Any condition that is unstable and could jeopardize the subject's participation in the
   study.