Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndr… (NCT03208296) | Clinical Trial Compass
SuspendedPhase 1/2
Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)
Stopped: Study did not start. Another protocol is being developed. Recruitment on hold.
United States24 participantsStarted 2017-12-01
Plain-language summary
The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS).
The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by
1. evaluating the histological clearance of BCCs in patients with BCNS, and
2. assessing the clinical changes of BCCs after treatment with ASN-002, and
3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions
4. assess the safety and clinical changes after a second cycle of ASN-002 injections
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must satisfy established criteria for the diagnosis of BCNS (Section 1.1.2, Table 1).
✓. Must have at least 4 target lesions, clinically consistent with BCC.
✓. Up to 6 target lesions, including each of the 3 or 4 to-be-injected lesions and 1 or 2 non-injected lesions must be biopsied.
✓. At least 3 target lesions, 2 to be injected and one to be non-injected, must be biopsy proven BCC per criteria in Synopsis Table 3: Modified Criteria for Low Risk BCC in BCNS Patients
✓. Removal of \< 25% of the area of the tumor by initial biopsy performed within 12 weeks before screening visit. A 2mm punch biopsy is recommended for histological confirmation of BCC.
✓. Screening laboratory values as follows:
✓. Neutrophil count \> 1500/mm3
✓. Hemoglobin \> 10 g/dL
Exclusion criteria
✕. Target tumor biopsy shows evidence of:
What they're measuring
1
Safety of ASN-002 will be studied in terms of AEs reported in individuals with Basal Cell Nevus Syndrome (BCNS) receiving ASN-002 using CTCAE 4.03.
Timeframe: The assessment will be conducted at every visit after first dose, week1, week2, week 3, Months1, 2, 3, 4 and at Month 6.
✕. Eastern Cooperative Oncology Group (ECOG) performance status \> 2.
✕. Known or suspected metastatic disease.
✕. Female participants must be non-lactating and non-pregnant.
✕. Clinically active or uncontrolled skin disease that would interfere with evaluation of the area surrounding the target tumor (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
✕. Known history of sensitivity to any of the ingredients in ASN-002.
✕. Immunocompromised (e.g. known hepatitis B or C or HIV infection) or is receiving or is expected to receive an immunomodulating agent (including immunosuppressive agents, cytotoxic drugs, biological agents, immunoglobulins, interferon or other immune or cytokine-based therapies; regular use of inhaled or oral corticosteroids at doses higher than replacement doses is an exclusion criterion).
✕. Treatment with psoralen plus UVA or UVB therapy within 3 months of screening and agrees not to receive such treatment until excision site is confirmed to be well healed at the post-surgery study visits