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

Status unconfirmed · Phase 1

Conditions studied: Ovarian Epithelial Cancer

In brief

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.

Key facts

Study ID

NCT03078400

Run by

Splash Pharmaceuticals, Inc.

People needed

14

Starts

2017-03-10

Expected to finish

2020-06-30

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females ≥18 years of age
• Platinum-resistant recurrent or metastatic epithelial ovarian carcinoma
• 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
• Status post first-line therapy with definitive surgery (which provided tissue for pathologic diagnosis) and chemotherapy
• Original diagnosis has been confirmed through a histopathologic review of the primary tumor slides by an expert pathologist at the Principal Investigator's institution
• Disease has progressed or recurred during or less than 6 months after platinum-based chemotherapy at some point during the subject's course.
• 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)
• Measurable disease by RECIST 1.1 criteria
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2
• Women with childbearing potential and partners must both use effective contraception during the study and for 3 months after the last dose
• Life expectancy of at least 6 months
• 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

You may not qualify if…

• Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
• 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)
• Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
• Concomitant use of other cytotoxic or cytostatic drugs other than PTX
• 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)
• Contraindication to the use of PTX
• Pregnancy or breast-feeding at time of Screening and throughout the study.
• Active, uncontrolled infection
• 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
• 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

Where it is running

• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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