A Phase I/IIa Study of the Efficacy and Safety of ASN-002 Alone and in Combination with 5-Fluorouracil (5-FU) in Adult Patients with Low-Risk Nodular Basal Cell Carcinoma

Phase 1

Completed

• Conditions: odular Basal Cell Carcinoma; Basal Cell Carcinoma Nevus Syndrome; Nodular Basal Cell Carcinoma; Cancer - Non melanoma skin cancer; Skin - Other skin conditions

• Registration Number: ACTRN12615001017516
• Lead Sponsor: Ascend Biopharmaceutical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-29
• Study Completion: 2018-06-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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 UVA or UVB 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified