At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
SOR007 (Uncoated Nanoparticle Paclitaxel) Ointmentdrug
Likely dose
SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment 0.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases
In Brief
A Phase 2 clinical trial evaluating SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment for Cutaneous Metastasis. Completed, enrolled 23 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Metastasis
CountriesUnited States
CollaboratorsUS Biotest, Inc.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJan 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedApr 5, 2017
Enrollment StartJan 31, 2018
Primary CompletionApr 29, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.2 years ago
Interventions
SOR007 (Uncoated Nanoparticle Paclitaxel) Ointmentdrug
One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.