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Trial record 2 of 4 for:    sor007

Study of Topical SOR007 Ointment for Cutaneous Metastases

This study is not yet open for participant recruitment.
Verified October 2017 by NanOlogy, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03101358
First Posted: April 5, 2017
Last Update Posted: October 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC
  Purpose
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.

Condition Intervention Phase
Cutaneous Metastasis Drug: SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment Phase 1 Phase 2

Study Type: Interventional
Study Design: 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
Official Title: Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases

Resource links provided by NLM:


Further study details as provided by NanOlogy, LLC:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events [ Time Frame: Baseline through Day 59 ]
    Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.


Secondary Outcome Measures:
  • Difference in total area of eligible lesion(s) in the treatment area [ Time Frame: Baseline and Day 43 ]
    Efficacy will be determined by the difference in the total area of eligible lesion(s) in the treatment area between baseline and Day 43 using analysis of photographs (taken at baseline and on Day 43) 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 43 ]

    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).

    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).


  • Reduction in pain at the treatment area [ Time Frame: Baseline and Day 43 ]
    Reduction in pain at the treatment area will be measured by the Numeric Rating Scale (NRS-11).

  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007 [ Time Frame: Baseline and Day 43 ]
  • Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007 [ Time Frame: Baseline and Day 43 ]
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007 [ Time Frame: Baseline and Day 43 ]

Estimated Enrollment: 24
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOR007 0.15%
0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
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.
Experimental: SOR007 1.0%
1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
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.
Experimental: SOR007 2.0%
2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
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.

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-ulcerated, 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. At each visit (Days 1, 8, 15, 29, and 43), at least two color photographs of the treatment area will be taken (with a ruler for scale). All eligible lesions within the treatment area will be measured using ImageJ and the photographs taken at each visit. 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 12 subjects at that dose.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, or parathyroid cancers;
  4. Biopsy confirmed cutaneous metastases; the biopsy must have removed ≤ 25% of the largest lesion within the treatment area and there must be at least 2 weeks but no more than 4 weeks between the date of biopsy and initiation of topical treatment with SOR007;
  5. ECOG Grade 0 - 1, with minimum life expectancy of at least 3 months;
  6. At least one baseline eligible lesion on the trunk or extremities. 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 other 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. Willing to use appropriate birth control for patients of child-bearing potential;
  10. 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 wounds at the site of cutaneous metastasis;
  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. Treatment with the following within the 4 weeks prior to the screening visit: radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy) to the target area, local hyperthermia, levulinic acid, 5-fluorouracil, high potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, imiquimod;
  5. Systemic cytotoxic chemotherapy for the treatment of cutaneous metastasis completed as of consent date;
  6. 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;
  7. Known allergic reactions, irritations or sensitivity to the active ingredients or other components of SOR007;
  8. 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;
  9. Participation in the treatment phase of another clinical trial within the four weeks prior to treatment in this clinical trial;
  10. Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
  11. Evidence of current chronic alcohol or drug abuse;
  12. Pregnancy and/or lactating.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101358


Contacts
Contact: Rose Marie Cavanna-Mast 805-595-1300 rosemarie.cavanna@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com

Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Study Director: Rose Marie Cavanna-Mast US Biotest
Principal Investigator: Julie E Lang, MD University of Southern California
  More Information

Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03101358     History of Changes
Other Study ID Numbers: SOR007-2017-01
First Submitted: March 29, 2017
First Posted: April 5, 2017
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NanOlogy, LLC:
cutaneous metastases
cutaneous metastasis
skin metastases
skin metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Skin Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action