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Trial record 2 of 4 for:    sor007

Study of Topical SOR007 Ointment for Cutaneous Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101358
Recruitment Status : Completed
First Posted : April 5, 2017
Results First Posted : November 4, 2021
Last Update Posted : November 5, 2021
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 5, 2017
Results First Submitted Date  ICMJE October 6, 2021
Results First Posted Date  ICMJE November 4, 2021
Last Update Posted Date November 5, 2021
Actual Study Start Date  ICMJE January 31, 2018
Actual Primary Completion Date April 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
Incidence of Treatment Emergent Adverse Events [ Time Frame: Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment) ]
Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Incidence of treatment emergent adverse events [ Time Frame: 42 Days ]
Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
  • Objective Clinical Response [ Time Frame: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment) ]
    Objective Clinical Response (Complete Clinical Response (CR) + Partial Response (PR)) is defined as the percentage of study subjects who achieve complete clinical response or partial response 14 days after last treatment (Day 43 or Day 70). Complete clinical response (CR) is defined as absence of any detectable residual disease in the treatment area; partial response (PR) as at least a 30% decrease in the sum of the diameters of eligible lesion(s) within the treatment area compared to baseline; progressive disease (PD) as at least a 20% increase in the sum of diameters of eligible lesion(s) within the treatment area, taking as reference the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); and stable disease (SD) as between that defined as PR or PD. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).
  • Change in Pain at the Treatment Area [ Time Frame: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment) ]
    Change in pain at the treatment area will be measured by the Numeric Rating Scale (NRS-11). The numerical scale ranges from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." A lower score equates to less severe pain (better outcome) and a higher score equates to more severe pain (worse outcome).
  • Objective Tumor Response (OTR) [ Time Frame: Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment) ]
    Objective Tumor Response (OTR), defined as the difference in the lesion size within the treatment area between baseline and 14 days after the last dose in the dose group i.e. Day 43 for dose escalation Subjects, and dose expansion Group A Subjects; Day 70 for dose expansion Group B Subjects; or between baseline and last tumor assessment for early terminators. Four OTRs are calculated based on different definitions of "lesion size": 1) Area of the primary eligible lesion, 2) Sum of area of all eligible lesions, 3) Longest diameter of the primary eligible lesion, and 4) Sum of longest diameter of all eligible lesions.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • Difference in total area of eligible lesion(s) in the treatment area [ Time Frame: Baseline and Day 42 ]
    Efficacy will be determined by the difference in the total area of eligible lesion(s) in the treatment area between baseline and Day 42 using analysis of photographs (taken at baseline and on Day 42) with a calibrated grid measurement system (ImageJ freeware) provided by the National Institutes of Health (NIH). Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).
  • Objective clinical response [ Time Frame: Baseline and Day 42 ]
    Objective Clinical Response (Complete Clinical Response (CR) + Partial Response (PR)) is defined as the percentage of patients who achieve complete clinical response or partial response 14 days after last treatment (Day 42). Complete clinical response (CR) is defined as absence of any detectable residual disease in the treatment area; partial response (PR) as at least a 30% decrease in the sum of the diameters of eligible lesion(s) within the treatment area compared to baseline; progressive disease (PD) as at least a 20% increase in the sum of diameters of eligible lesion(s) within the treatment area, taking as reference the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); and stable disease (SD) as between that defined as PR or PD. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Topical SOR007 Ointment for Cutaneous Metastases
Official Title  ICMJE Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases
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.
Detailed Description

This is a Phase 1/2, open-label, dose-rising study evaluating the safety, tolerability and preliminary efficacy of three concentrations of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment (0.15%, 1.0%, and 2.0%) applied to non-melanoma cutaneous metastases. A treatment area of 50 cm2 will be selected by the Investigator. Using a gloved hand, subjects will apply one Finger Tip Unit (FTU) of SOR007 to the 50 cm2 treatment area twice daily at approximately the same time each day for 28 days, with the option of extending treatment an additional 28 days to total 56 days for subjects in the dose expansion phase. At each visit (Days 1, 8, 15, 29, and 43 for 28 treatment days; Days 8, 15, 29, 57, and 70 for 56 treatment days), at least two global and two close-up color photographs of the treatment area will be taken (with a ruler for scale). The photographs will be analyzed with ImageJ. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter). The study will include a dose escalation phase and a dose expansion phase.

In the dose escalation phase, formal safety reviews will be conducted after the last subject in each cohort of three subjects completes 15 days of treatment. The next dose level will enroll upon a finding of safety and tolerability. The top dose or the maximum tolerated dose (if DLT occurs) will be taken into the dose expansion phase and additional subjects will be enrolled to reach a maximum of 16 subjects at that dose.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Metastasis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: SOR007 0.15%
    0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
    Intervention: Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
  • Experimental: SOR007 1.0%
    1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
    Intervention: Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
  • Experimental: SOR007 2.0%
    2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days
    Intervention: Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2017)
24
Actual Study Completion Date  ICMJE April 29, 2020
Actual Primary Completion Date April 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent;
  2. Male and female patients ≥ 18 years of age;
  3. 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;
  4. 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;
  5. ECOG Grade 0 - 2, with minimum life expectancy of at least 3 months;
  6. 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;
  7. Willing to refrain from using lotions, creams, etc. during the treatment period;
  8. 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;
  9. 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
  10. Willing to use appropriate birth control for patients of child-bearing potential;
  11. Abstinence from all manner of physical contact near the treatment area during and up to 2 weeks after the treatment phase.

Exclusion Criteria:

  1. Open or ulcerated wound(s) extending through the dermis within the treatment area;
  2. Colorectal, hepatocellular, gallbladder, cholangiocarcinoma, neuroendocrine, melanomas, hematological and central nervous system (CNS) malignancies;
  3. Active viral hepatitis A, B, or C or preexisting or acute liver disease;
  4. 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;
  5. 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;
  6. Known allergic reactions, irritations or sensitivity to the active ingredients or other components of SOR007;
  7. 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;
  8. Participation in the treatment phase of another clinical trial within the four weeks prior to treatment in this clinical trial;
  9. Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
  10. Evidence of current chronic alcohol or drug abuse;
  11. Pregnancy and/or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101358
Other Study ID Numbers  ICMJE SOR007-2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE
Study Director: Rose Marie Cavanna-Mast US Biotest
Principal Investigator: Julie E Lang, MD University of Southern California
PRS Account NanOlogy, LLC
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP