An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Inclusion Criteria:

- At least 18 years of age

- Ability to understand the purposes and risks of the study and has signed a written
informed consent form approved by the investigator's IRB/Ethics Committee

- Pathologically confirmed diagnosis of soft tissue sarcoma

- Locally advanced unresectable or metastatic disease with no standard curative therapy
available that has progressed since the most recent therapy

- Measurable disease by RECIST criteria with at least one target lesion

- 1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2

- A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or
other anti-tumor therapy and study entry

- Recovered from reversible toxicities of prior therapy

- Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL

- Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases)

- Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated
by Cockcroft-Gault formula

- All women of childbearing potential must have a negative serum pregnancy test and all
subjects must agree to use effective means of contraception (surgical sterilization
or the use of barrier contraception with either a condom or diaphragm in conjunction
with spermicidal gel or an IUD) from entry into the study through 6 months after the
last dose

Exclusion Criteria:

- Soft tissue sarcoma of the following subtypes: gastrointestinal stromal tumor (GIST),
alveolar soft parts sarcoma, hemangiopericytoma and Kaposi's sarcoma

- Most recent relapse occurring during treatment with ifosfamide within 4 weeks of last
dose

- Symptomatic brain or leptomeningeal metastases

- Active clinically significant infection requiring antibiotics

- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or
4), particularly coronary artery disease, arrhythmias or conduction defects with risk
of cardiovascular instability, uncontrolled hypertension, clinically significant
pericardial effusion, cerebrovascular accident or congestive heart failure

- Previously treated malignancies, except for adequately treated non-melanoma skin
cancer, in situ cancer, or other cancer from which the subject has been disease-free
for at least 5 years

- Major surgery within 3 weeks of the start of study treatment, without complete
recovery

- Females who are pregnant or breast-feeding

- Participation in an investigational drug or device study within 21 days of study
entry

- Concomitant disease or condition that could interfere with the conduct of the study,
or that in the opinion of the investigator would pose an unacceptable risk to the
subject in this study

- Unwillingness or inability to comply with the study protocol for any other reason