- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101358
Study of Topical SOR007 Ointment for Cutaneous Metastases
Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- University of Southern California
-
Santa Monica, California, United States, 90403
- Sarcoma Oncology Center
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Texas
-
Houston, Texas, United States, 77030
- Houston Methodist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- Abstinence from all manner of physical contact near the treatment area during and up to 2 weeks after the treatment phase.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SOR007 0.15%
0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days
|
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
|
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 or up to 56 days
|
One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline through Day 59 (for 28 days of treatment) or Day 86 (for 56 days of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
|
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).
|
Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
|
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.
|
Baseline and Day 43 (for 28 days of treatment) or Day 70 (for 56 days of treatment)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rose Marie Cavanna-Mast, US Biotest
- Principal Investigator: Julie E Lang, MD, University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Neoplastic Processes
- Neoplasm Metastasis
- Skin Neoplasms
- Neoplasms, Second Primary
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- SOR007-2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous Metastasis
-
Alpha Tau Medical LTD.RecruitingSkin Cancer | Cutaneous Tumor | Cutaneous MetastasisFrance
-
Copenhagen University Hospital at HerlevWithdrawnUlcerated Cutaneous MetastasesDenmark
-
Melanoma Institute AustraliaWithdrawnMelanoma | In-Transit Metastasis of Cutaneous MelanomaAustralia
-
Nicholas GulatiRecruitingCutaneous MetastasesUnited States
-
Herlev HospitalCompleted
-
Leiden University Medical CenterPierre Fabre LaboratoriesRecruitingMelanoma Stage III | In-Transit Metastasis of Cutaneous MelanomaNetherlands
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingClinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Clinical Stage 0 Cutaneous Melanoma AJCC v8 | Clinical Stage I Cutaneous Melanoma AJCC v8 | Clinical Stage IA Cutaneous Melanoma AJCC v8 | Clinical... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Melanoma | Unresectable Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Metastatic Merkel Cell Carcinoma | Metastatic Skin... and other conditionsUnited States
-
EMD SeronoMerck KGaA, Darmstadt, GermanyCompletedN-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous MelanomaUnited States, Sweden, Australia, France, Italy, South Africa, Spain, United Kingdom, Germany, Netherlands, Israel, New Zealand, Belgium, Switzerland
-
Jonsson Comprehensive Cancer CenterBristol-Myers Squibb; Array BioPharmaRecruitingMetastatic Cutaneous Melanoma | Unresectable Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Pathologic Stage III Cutaneous... and other conditionsUnited States
Clinical Trials on SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment
-
DFB Soria, LLCUS Biotest, Inc.Completed
-
DFB Soria, LLCUS Biotest, Inc.WithdrawnCervical Intraepithelial Neoplasia
-
DFB Soria, LLCBioskin GmbH; US Biotest, Inc.CompletedPlaque PsoriasisUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Breast Carcinoma | Stage IV Breast Cancer AJCC v6 and v7 | Stage III Breast Cancer AJCC v7 | Stage IIIA Breast Cancer AJCC v7 | Stage IIIB Breast Cancer AJCC v7 | Stage IIIC Breast Cancer AJCC v7 | Metastatic Breast Carcinoma | Locally Advanced Breast CarcinomaUnited States
-
University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletedRecurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung CancerUnited States
-
Anne NoonanNational Cancer Institute (NCI)RecruitingStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Urothelial Carcinoma | Stage IV Bladder Urothelial CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingInvasive Breast Carcinoma | Triple-Negative Breast Carcinoma | Breast AdenocarcinomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | Skin MetastasesUnited States