p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246

Inclusion criteria

• Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
• Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
• At least a single measurable lesion
• Adequate organ function prior to registration
• Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
• ECOG performance status of 0 to 2

Exclusion criteria

• Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
• Hypersensitivity to PLD or to any of the excipients
• Unable to undergo imaging by either CT scan or MRI
• Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
• Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed