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

• Status: Active, not recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy for up to 6 months, until disease progression or unacceptable toxicity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Splash Pharmaceuticals, Inc.
• Treatments: Paclitaxel

Criteria

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