Study of Topical SOR007 Ointment for Cutaneous Metastases

NCT03101358 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: SOR007-2017-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

cutaneous metastases; cutaneous metastasis; skin metastases; skin metastasis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

  Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment)

Secondary Outcomes (3)

• Objective Clinical Response

  Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

• Change in Pain at the Treatment Area

  Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

• Objective Tumor Response (OTR)

  Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)

Study Arms (3)

SOR007 0.15%

EXPERIMENTAL

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment

SOR007 1.0%

EXPERIMENTAL

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment

SOR007 2.0%

EXPERIMENTAL

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days

Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment

Interventions

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment DRUG

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

SOR007 0.15%; SOR007 1.0%; SOR007 2.0%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Male and female patients ≥ 18 years of age;
• 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;
• Cutaneous metastases diagnosis confirmed prior to consent by preferred institutional methodology which may include, but is not limited to: biopsy; conventional radiography; imaging techniques to include bone scan (scintigraphy), computed tomography (CT), fluorodeoxyglucose-positron emission tomography (FDG-PET)/CT), magnetic resonance imaging (MRI), F-fluoromisonidazole-(F-FMISO) PET/CT, fluorothymidine-(FLT) PET/CT, fluoroestradiol-(FES) PET/CT, and PET/MRI;
• ECOG Grade 0 - 2, with minimum life expectancy of at least 3 months;
• At least one baseline eligible lesion. Per RECIST criteria (version 1.1), an eligible lesion at baseline is considered measurable when ≥ 10mm diameter in the longest diameter;
• Willing to refrain from using lotions, creams, etc. during the treatment period;
• Subjects with adequate organ and bone marrow function as defined below:
• ANC ≥ 1,500/µl
• Hemoglobin ≥ 9.5 grams/dL
• Platelets ≥ 75,000/µl
• AST (aspartate transaminase or SGOT)/ALT (alanine aminotransferase or SGPT) ≤ 3.0 x ULN and total bilirubin ≤ 2.0 x ULN with no evidence of cholestasis
• Creatinine ≤ 1.5x ULN;
• Last dose of any systemic non-taxane cytotoxic chemotherapy completed at least one day prior to Day 1. Last dose of any systemic taxane cytotoxic chemotherapy completed at least 4 weeks prior to Day 1
• Willing to use appropriate birth control for patients of child-bearing potential;

You may not qualify if:

• Open or ulcerated wound(s) extending through the dermis within the treatment area;
• Colorectal, hepatocellular, gallbladder, cholangiocarcinoma, neuroendocrine, melanomas, hematological and central nervous system (CNS) malignancies;
• Active viral hepatitis A, B, or C or preexisting or acute liver disease;
• Systemic treatment or localized treatment to target area with the following within the 4 weeks prior to the first treatment visit: radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy), local hyperthermia, levulinic acid, 5-fluorouracil, high potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, imiquimod;
• Elective surgery for treatment of the cutaneous metastases during the study and up to 4 weeks after the treatment period. Cutaneous metastases are required to remain in-situ and measurable for up to 2 weeks after last treatment to achieve study objectives;
• Known allergic reactions, irritations or sensitivity to the active ingredients or other components of SOR007;
• Symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
• Participation in the treatment phase of another clinical trial within the four weeks prior to treatment in this clinical trial;
• Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
• Evidence of current chronic alcohol or drug abuse;
• Pregnancy and/or lactating.

Sponsors & Collaborators

• NanOlogy, LLC: lead
• US Biotest, Inc.: collaborator

Study Sites (4)

University of Southern California

Los Angeles, California, 90089, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lacouture ME, Goldfarb SB, Markova A, Chawla SP, Dewnani K, Iacobucci M, Lang JE. Phase 1/2 study of topical submicron particle paclitaxel for cutaneous metastases of breast cancer. Breast Cancer Res Treat. 2022 Jul;194(1):57-64. doi: 10.1007/s10549-022-06584-6. Epub 2022 Apr 26.

  PMID: 35471470 DERIVED

MeSH Terms

Interventions

Ointments

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Gere diZerega, MD
• Organization: US Biotest, Inc.

gere.dizerega@usbiotest.com

805.595.1300

Study Officials

• Rose Marie Cavanna-Mast

  US Biotest

  STUDY DIRECTOR

• Julie E Lang, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1/2, open-label, dose-rising trial of three concentrations of SOR007 (0.15%, 1.0%, 2.0%). During the dose escalation phase, the study will follow a standard 3+3 dose-ascending design. If a single dose limiting toxicity (DLT) is identified in one of three subjects in the cohort, a further three subjects will be enrolled at the same dose level. If one or more DLT occur in the three additional subjects enrolled in the cohort, dose escalation will stop and the prior dose level will be regarded 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. In the dose expansion phase, additional subjects will be enrolled up to a maximum of 12 subjects at the dose determined to be the MTD (or the top dose, 2.0% SOR007).

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 5, 2017
• Study Start: January 31, 2018
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: November 5, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)