PTX-200 and Carboplatin in Ovarian Cancer

The purpose of this study is to investigate the safety and tolerability, and determine the
maximum tolerated dose of triciribine when combined with carboplatin in women with
platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to
evaluate the clinical activity of carboplatin plus triciribine in women with
recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate,
progression-free survival, and duration of stable disease.

Inclusion Criteria:

- At least 18 years of age

- Histologically confirmed, measurable or non-measurable, recurrent or persistent,
platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is
defined by a disease-free interval of less than 6 months following treatment with a
platinum-based regimen, or the progression of disease during platinum-based therapy.

- At least one prior regimen of chemotherapy, with no maximum number of chemotherapy
cycles

- A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry

- Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000
mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3

- Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine
transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤
1.5 mg/dl

- Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2

- Life expectancy of at least 90 days

- The patient should be off chemotherapy, biologic therapy and radiation for 28 days.

- Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity
Criteria (CTC) version 4

Exclusion Criteria:

- Prior TCN-PM therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TCN-PM

- Patients must be disease-free of prior invasive malignancies for >2 years with the
exception of basal cell or squamous cell carcinoma of the skin.

- Inability to give informed consent

- Pregnancy

- Corrected QT interval (QTc) prolongation > 450 milliseconds (msec)