Abstract OT1-07-01: Phase 1/2 study of topical SOR007 (nanoparticle paclitaxel ointment) for cutaneous metastasis
Authors: Lang JE , Chawla S , Chang J , diZerega G , Cavanna-Mast RM , Savoie C , Lacouture M 
Published: May 2019

Abstract
Background: Cutaneous metastases are common in non-skin cancers, resulting in considerable morbidity, infection, pain, and negatively impacting quality of life. No standard of care exists for effective control of cutaneous metastases, which is a significant unmet need in oncology. Paclitaxel has shown effectiveness in the treatment of ovarian, breast, non-small cell lung, and pancreatic cancers and is approved by the United States Food and Drug Administration for the systemic treatment of many types of malignancies. We hypothesize that SOR007, or nanoparticulate paclitaxel ointment may be well tolerated and effective in the treatment of cutaneous metastases.
Trial Design: This trial is a Phase 1/2, open-label study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 (0.15%, 1.0%, and 2.0%) ointment applied topically, twice daily, to non-melanoma cutaneous metastases during a 3+3 dose-ascending or dose expansion phase. Subjects will self-apply SOR007 ointment twice daily on Days 1 to 28, to a 50 cm2 area containing an eligible lesion. If a single dose limiting toxicity (DLT) is identified in the three subjects, an additional three subjects will be enrolled at the same dose level. If one or more DLT occur in the three additional subjects, dose escalation will stop and the prior dose level will be determined as the Maximum Tolerated Dose (MTD) and taken forward into the dose expansion phase. If no further DLT are identified, dose escalation will continue, until either a DLT is identified at a higher dose or the top dose of 2% is reached. Once DLT is determined, additional subjects will be enrolled in the expansion phase, to total up to 12 subjects at the top dose.
Specific Aims: 1) The primary objective of this study is to determine preliminary safety and tolerability of topical SOR007. Secondary endpoints include: 2) evaluating preliminary efficacy based on RECIST criteria, photograph documentation of lesion size in longest diameter, and objective clinical response. 3) We will evaluate potential reduction in pain at the treatment area. 4) We will determine the peripheral blood pharmacokinetics of topical SOR007 applied to cutaneous metastases.
Eligibility criteria: Male and female patients over the age of 18 with malignancies resulting in cutaneous metastasis originating from: breast, lung, head and neck, pancreatic, urinary bladder, prostate, testicular, ovarian, uterine, cervical, gastric, adrenal, thyroid, parathyroid cancers or other solid tumors which previously responded to taxane treatment are eligible to participate. Patients' last dose of any systemic non-taxane cytotoxic chemotherapy should be completed at least one day prior to the trial. Patients' last dose of any systemic taxane cytotoxic chemotherapy should be completed at least 4 weeks prior to the trial. Patients should be ECOG 0-2 with a minimum life expectancy of at least 3 months. Open or ulcerated wound(s) extending through the dermis are not eligible.
Statistical methods: Data will be analyzed by descriptive statistics.
Present accrual and target accrual: To date, we have enrolled 3 of a maximum of 24 subjects.
Citation Format: Lang JE, Chawla S, Chang J, diZerega G, Cavanna-Mast RM, Savoie C, Lacouture M. Phase 1/2 study of topical SOR007 (nanoparticle paclitaxel ointment) for cutaneous metastasis [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-07-01.