Basal Cell Nevus Syndrome Clinical Trial
— ASN-002-001Official title:
A Phase 1/2a Study of the Efficacy and Safety of ASN-002 Alone or in Combination With 5-FU in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
Verified date | June 2018 |
Source | Ascend Biopharmaceuticals Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal
cell carcinoma (nBCC) in patients aged 18 years or over.
The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU
for 3 weeks and undergo surgical excision of the tumor.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Low risk nodular basal cell carcinoma 2. Biopsy of any other skin tumor 3. Willingness to have injection therapy followed by surgery 4. Written informed consent Exclusion Criteria: 1. No or only minimal symptoms 2. Known or suspected metastatic disease. 3. Pregnant or Lactating females 4. Clinically active or uncontrolled skin disease 5. Immunocompromised or receiving immunomodulating agent 6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months 7. Any serious or active medical or psychiatric illness 8. Recreational or therapeutic drug or alcohol use 9. Taking any investigational product within 1 month of first dose of ASN- 002. |
Country | Name | City | State |
---|---|---|---|
Australia | Siller Medical T/A Central Brisbane Dermatology | Brisbane | Queensland |
Australia | Veracity Clinical Research | Brisbane | Queensland |
Australia | St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales |
Australia | Sinclair Dermatology | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Ascend Biopharmaceuticals Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC | changes in vital signs, adverse events, serious adverse events, laboratory abnormalities and withdrawals from study. Local skin and injection site reactions will be assessed in detail scoring erythema, ulceration, pain and overall severity as none, mild, moderate or severe. | Participants will be followed up for up to 6 months. | |
Secondary | Microscopic clearance of the injected basal cell carcinoma. | Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests in serial histological samples as determined by central pathology review. | Microscopic examinations of sample collected at 17weeks after the first dose. | |
Secondary | Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU | Change in nBCC lesion size will be assessed by investigator at baseline and then every 4 weeks until the surgical excision of BCC after ASN-002 therapy. | Change in nBCC will be assessed for up to 6 months from the first treatment visit. |
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