Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

Inclusion Criteria

• •Participants must sign an approved informed consent form (ICF).
• •Participants must be ≥ 18 years of age.
• •Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• •Participants must have primary or secondary platinum-resistant ovarian cancer.
• •Participants must have at least a single (RECIST v1.1-defined) measurable lesion.
• •For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline radiological imaging must include an evaluation of the head.
• •Participants must have had prior debulking surgery.
• •Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens.
• •Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the management of ovarian cancer.
• •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• •Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities.
• •Participants must have adequate organ function including:
• •1. Bone Marrow Reserve:
• •1. Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
• •2. Platelets ≥ 100x10\^9/L
• •3. Hemoglobin ≥ 9 g/dL
• •2. Hepatic: Total bilirubin level \< 1.5 x ULN and ALT, AST, GGT, and alkaline phosphatase levels \< 2.5 x ULN.
• •3. Renal: Serum creatinine level ≤ 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance ≥ 50 mL/min/1.73m\^2
• •4. Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal.