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VT30 for Lymphatic Malformations

Phase 1 & 2
Waitlist Available
Research Sponsored by Venthera, Inc., a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-treatment to 4 weeks
Awards & highlights

Study Summary

This trial is a 2-part study of a new drug, VT30, to treat venous malformations, lymphatic malformations, or mixed venolymphatic malformations associated with PIK3CA or TEK mutations. The first part is a 4-week treatment to determine safety and tolerability of the drug. The second part is a 12-week treatment to study efficacy of the drug.

Eligible Conditions
  • Lymphatic Malformations
  • Venous Malformations

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-treatment to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-treatment to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of safety and tolerability
Secondary outcome measures
Maximum feasible dose / maximum tolerable dose
Tissue and serum drug levels
Other outcome measures
Changes in Pain
Changes in lesion
Changes in management of lesion bleeding, oozing, or discharge
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VT30Experimental Treatment1 Intervention
VT30 is a PI3K-inhibitor prodrug, formulated as a topical gel and dispensed from a metered dose pump; administration is once or twice daily, applied to target-treatment area(s) on the skin. One pump action dispenses 250 µL of gel, intended to treat an area of 140 cm2.

Find a Location

Who is running the clinical trial?

Venthera, Inc., a BridgeBio companyLead Sponsor
Ken Truitt, MDStudy DirectorVenthera, Inc., a BridgeBio company
Michael HendersonStudy DirectorVenthera, Inc., a BridgeBio company
2 Previous Clinical Trials
3,398 Total Patients Enrolled

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
First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations
2020. "First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04409145.
~3 spots leftby Apr 2025
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