Clinical Trials

Inclusion Criteria:

• Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
• Aged 18 years or older.
• Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1.
• Platinum-resistant disease (defined as progression within ≤ 6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).
• Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
• Received at least 1 but not more than 4 prior therapy regimens.
  • Note: maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
• Measurable disease according to RECIST v1.1 criteria.

Exclusion Criteria:

• Tumors in the breast or bone.
• Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy).
• Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on > 10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
• Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen).
• Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
• Received prior therapy with PAC in the recurrent setting.