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Safety Phase for Ovarian Cancer

Phase 1
Waitlist Available
Led By June Girda, MD
Research Sponsored by Splash Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until dose-limiting toxicity, disease progression or 6 months
Awards & highlights

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.

Eligible Conditions
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until dose-limiting toxicity, disease progression or 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and until dose-limiting toxicity, disease progression or 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (Safety)
Secondary outcome measures
Response to Investigational Product

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety PhaseExperimental Treatment1 Intervention
Six to 12 subjects Cohort 1 SPL-108 injection daily + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles Cohort 2 SPL-108 BID injection + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles
Group II: Exploratory Expansion PhaseExperimental Treatment1 Intervention
Up to 12 subjects • Cohort 3: SPL-108 daily dose (to be determined in Arm I) + 80 mg/m2 PTX weekly on Days 1, 8, and 15 in 28 day cycles.

Find a Location

Who is running the clinical trial?

Splash Pharmaceuticals, Inc.Lead Sponsor
June Girda, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer
2017. "Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03078400.
~2 spots leftby Apr 2025
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