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

NCT02550678 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-06-06

No results posted yet for this study

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.

Conditions

  • Basal Cell Nevus Syndrome
  • Skin Neoplasm
  • Nodular Basal Cell Carcinoma of Skin

Interventions

BIOLOGICAL

ASN-002

ASN-002, is made of a suspension of recombinant adenoviral particles carrying a gene coding for the human interferon-gamma (IFN). Study participants will receive protocol defined dose of ASN-002 as intra-tumoral injections.

DRUG

5-FU

5-FU is chemotherapeutic agent used to treat various cancers.

Sponsors & Collaborators

  • Ascend Biopharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Lynda Spelman · Veracity Clinical Research Pty Ltd.

  • Rodney Sinclair · Sinclair Dermatology Pty Ltd

  • Gregory Siller · Siller Medical T/A Central Brisbane Dermatology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550678 on ClinicalTrials.gov