A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

Inclusion Criteria:

1. Have histologically confirmed ovarian cancer that is potentially sensitive to
DOXIL/CAELYX

2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one
of which was platinum based.

3. Be DOXIL/CAELYX treatment naïve

4. Have a normal left ventricular ejection fraction (LVEF) based on institutional
ranges.

5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of
6. Have an estimated life expectancy of ≥ 3 months

7. Be >/= 18 and
8. Sign a written Institutional Review Board (IRB)-approved informed consent form

9. Have a negative pregnancy test, if patient is of child-bearing potential

10. Have acceptable liver function:

- Bilirubin
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase normal

11. Have acceptable renal function:

- Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

12. Have acceptable hematologic status:

- Neutrophils >/= 1500 cells/mm3

- Platelet count >/= 100,000 (plt/mm3)

- Hemoglobin >/= 9 g/dL

13. Have acceptable coagulation status:

- Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN

- Partial thromboplastin time (PTT) within 1.5 × ULN

14. Agree to use effective contraceptive methods during the study (nonsterile patients of
childbearing potential)

Exclusion Criteria:

1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial
infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence
of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14
days prior to Day 1

2. Have received > 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or
similar compounds

3. Have received prior treatment with DOXIL/CAELYX

4. Have received radiotherapy to the mediastinal area or concomitant therapy with other
potentially cardiotoxic agents

5. Have seizure disorders requiring anticonvulsant therapy

6. Have known brain metastases (unless previously treated and well controlled for a
period of >/= 3 months)

7. Have severe chronic obstructive pulmonary disease with hypoxemia

8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1

9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic
infections requiring systemic therapy

10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must
agree to use adequate contraception (hormonal or barrier method of birth control; or
abstinence) prior to study entry and for the duration of study participation. Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she must inform her treating physician immediately.

11. Have received treatment with radiation therapy, surgery, chemotherapy, or
investigational therapy within one month prior to study entry (6 weeks for
nitrosoureas or Mitomycin C).

12. Have received radiation therapy to >25% of her total bone marrow during her lifetime

13. Are unwilling or unable to comply with procedures required in this protocol

14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or
hepatitis C

15. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure,
significantly impaired hepatic function, or other conditions) that could compromise
protocol objectives in the opinion of the investigator and/or the sponsor

16. Are currently receiving any other investigational agent

17. Have exhibited allergic reactions to doxorubicin or a similar structural compound