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

NCT03078400 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-03-18

No results posted yet for this study

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.

Conditions

  • Ovarian Epithelial Cancer

Interventions

DRUG

SPL-108

Subcutaneous injection of 150 mg administered either one time or two times per day.

Sponsors & Collaborators

  • Splash Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • June Girda, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2020-01-31
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078400 on ClinicalTrials.gov