A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy

Inclusion Criteria:

- Females ≥18 years of age

- Histologically or cytologically documented primary epithelial ovarian carcinoma,
cancer of the Fallopian tube, or primary peritoneal carcinoma

- Completion of first-line chemotherapy

- Clinical remission as a result of chemotherapy

- History of normal CA125 level after initial course of therapy

- CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which
are mutually >= 28 days apart, provided that:

1. the 3rd sample is above the institution's ULN, and

2. the 3rd sample is confirmed by a 4th sample which is likewise higher than the
2nd sample value and is above the institution's ULN

- No clinically evident disease progression, as assessed by history, physical
examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)

- ECOG Performance Status of 0 or 1

- No clinically significantly abnormal clinical laboratory tests or concomitant
illnesses

- Ability and willingness to self-administer subcutaneous injections

- Although pregnancy is extremely unlikely in this patient population because of the
disease and prior treatment, patients who have the potential to become pregnant must
have a negative pregnancy test and must agree to practice an effective method of
contraception throughout the trial.

Exclusion Criteria:

- Persistent adverse events due to agents administered more than 4 weeks earlier

- More than 1 course of previous chemotherapy for the qualifying cancer

- Disease requiring chemotherapy or radiotherapy

- Ascites

- Recent history of active infection, gastrointestinal bleeding, thromboembolic
disorders, or anticoagulation