MedTrace Logo

Study of Topical SOR007 Ointment for Cutaneous Metastases

NCT03101358 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-11-05

Study results available
· View outcomes & findings →

Summary

This study evaluates a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of cutaneous metastases from non-melanoma cancer in adults. Three concentrations of SOR007 will be evaluated in dose-rising cohorts of three. An expanded cohort will treat additional subjects at the maximum tolerated dose.

Conditions

  • Cutaneous Metastasis

Interventions

DRUG

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment

One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Rose Marie Cavanna-Mast · US Biotest

  • Julie E Lang, MD · University of Southern California

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-04-29
Completion
2020-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03101358 on ClinicalTrials.gov