Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer

This is an interventional treatment trial for Ovarian Epithelial Cancer Read More

Inclusion Criteria:

1. Females ≥18 years of age
2. Platinum-resistant recurrent or metastatic epithelial ovarian carcinoma
3. Positivity on CD44 assay as defined by strong (+++) or moderate (++) staining in 20% or more of the tumor tissue/stroma as obtained by biopsy or paracentesis
4. Status post first-line therapy with definitive surgery (which provided tissue for pathologic diagnosis) and chemotherapy
5. Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
6. Disease has progressed or recurred during or less than 6 months after platinum-based chemotherapy at some point during the subject's course.
7. No more than 3 prior regimens of cytotoxic chemotherapy unless approved by the sponsor (Note: all platinum-containing regimens are not to be counted separately but are considered to be a single regimen for the purposes of this criterion)
8. Measurable disease by RECIST 1.1 criteria
9. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
10. Women with childbearing potential and partners must both use effective contraception during the study and for 3 months after the last dose
11. Life expectancy of at least 6 months
12. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure

Exclusion Criteria:

1. Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
2. Fewer than 28 days before Cycle 1 Day 1 since any prior chemotherapy (less than 42 days in the case of mitomycin or a nitrosourea)
3. Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
4. Concomitant use of other cytotoxic or cytostatic drugs other than PTX

5. Abnormal clinical laboratory values within 14 days prior to initiation of dosing, as indicated by:

   • Hemoglobin level <9.0 gm/L
   • Platelet count <100,000/mm3
   • Granulocyte count <1500/mm3
   • Serum creatinine level ≥2.5 mg/dL (221 μmol/L)
   • Liver aminotransferase levels greater than 3 times the laboratory's upper limit of normal (greater than 5 times the laboratory's upper limit of normal if the liver is known to be involved with tumor)
6. Contraindication to the use of PTX
7. Pregnancy or breast-feeding at time of Screening and throughout the study.
8. Active, uncontrolled infection
9. Participation in another investigational drug trial concurrently or within 30 days of Cycle 1 Day 1, or a vaccine trial within 90 days of Cycle 1 Day 1
10. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the trial, and/or compromise the objectives of the trial