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

NCT02550678 | Completed Phase 1

• 1 other identifier: ASN-002-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Untreated nBCC; Low-Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Microscopic clearance of the injected basal cell carcinoma.

  Microscopic examinations of sample collected at 17weeks after the first dose.

• Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU

  Change in nBCC will be assessed for up to 6 months from the first treatment visit.

Study Arms (5)

Cohort 1

EXPERIMENTAL

Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.

Biological: ASN-002

Cohort 2

EXPERIMENTAL

Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks

Biological: ASN-002

Cohort 4

EXPERIMENTAL

Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Biological: ASN-002

Cohort 5

EXPERIMENTAL

Study Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Biological: ASN-002

Combination Cohorts

EXPERIMENTAL

Study Participants will receive ASN- 002 at either dose of Cohorts II, IV or V in combination with a low dose 5-FU (1mg/2.5 mg/5mg/10mg or 25mg) weekly injections in tumor nodules for 3 weeks.

Biological: ASN-002; Drug: 5-FU

Interventions

ASN-002 BIOLOGICAL

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.

Cohort 1; Cohort 2; Cohort 4; Cohort 5; Combination Cohorts

5-FU DRUG

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

Combination Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low risk nodular basal cell carcinoma
• Biopsy of any other skin tumor
• Willingness to have injection therapy followed by surgery
• Written informed consent

You may not qualify if:

• No or only minimal symptoms
• Known or suspected metastatic disease.
• Pregnant or Lactating females
• Clinically active or uncontrolled skin disease
• Immunocompromised or receiving immunomodulating agent
• treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months
• Any serious or active medical or psychiatric illness
• Recreational or therapeutic drug or alcohol use
• Taking any investigational product within 1 month of first dose of ASN- 002.

Sponsors & Collaborators

• Ascend Biopharmaceuticals Ltd: lead

Study Sites (4)

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, 2217, Australia

Location

Siller Medical T/A Central Brisbane Dermatology

Brisbane, Queensland, 4000, Australia

Location

Veracity Clinical Research

Brisbane, Queensland, 4102, Australia

Location

Sinclair Dermatology

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Basal Cell Nevus Syndrome; Skin Neoplasms

Interventions

gusacitinib; Fluorouracil

Condition Hierarchy (Ancestors)

Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Carcinoma, Basal Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lynda Spelman

  Veracity Clinical Research Pty Ltd.

  PRINCIPAL INVESTIGATOR

• Rodney Sinclair

  Sinclair Dermatology Pty Ltd

  PRINCIPAL INVESTIGATOR

• Gregory Siller

  Siller Medical T/A Central Brisbane Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)