A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascend Biopharmaceuticals Ltd

Criteria

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.