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Anti-mitotic Agent

SOR007 1.0% for Metastasis

Phase 1 & 2
Waitlist Available
Led By Julie E Lang, MD
Research Sponsored by NanOlogy, LLC
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 baseline and day 43 (for 28 days of treatment) or day 70 (for 56 days of treatment)
Awards & highlights

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.

Eligible Conditions
  • Metastasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 59 (for 28 days of treatment) or day 86 (for 56 days of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 59 (for 28 days of treatment) or day 86 (for 56 days of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment Emergent Adverse Events
Secondary study objectives
Change in Pain at the Treatment Area
Objective Clinical Response
Objective Tumor Response (OTR)

Side effects data

From 2020 Phase 1 & 2 trial • 23 Patients • NCT03101358
33%
Application site pruritus
33%
Urinary tract infection fungal
33%
Pruritus generalised
33%
Application site pain
33%
Erythema
33%
Abdominal pain upper
33%
Loose tooth
33%
Blepharitis
33%
Pruritus
33%
Headache
33%
Anxiety
33%
Skin lesion
33%
Urticaria
33%
Depression
33%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SOR007 1.0%
SOR007 2.0% Group B
SOR007 0.15%
SOR007 2.0% Group A

Trial Design

3Treatment groups
Experimental Treatment
Group I: SOR007 2.0%Experimental Treatment1 Intervention
2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days
Group II: SOR007 1.0%Experimental Treatment1 Intervention
1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
Group III: SOR007 0.15%Experimental Treatment1 Intervention
0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

NanOlogy, LLCLead Sponsor
10 Previous Clinical Trials
155 Total Patients Enrolled
US Biotest, Inc.Industry Sponsor
17 Previous Clinical Trials
345 Total Patients Enrolled
Rose Marie Cavanna-MastStudy DirectorUS Biotest
~3 spots leftby Sep 2025
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