COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02550678




Registration number
NCT02550678
Ethics application status
Date submitted
10/09/2015
Date registered
15/09/2015
Date last updated
6/06/2018

Titles & IDs
Public title
A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
ASN-002-001
Universal Trial Number (UTN)
Trial acronym
ASN-002-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Nevus Syndrome 0 0
Skin Neoplasm 0 0
Nodular Basal Cell Carcinoma of Skin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ASN-002
Treatment: Drugs - 5-FU

Experimental: Cohort 1 - Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.

Experimental: Cohort 2 - Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks

Experimental: Cohort 4 - Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Experimental: Cohort 5 - Study Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.

Experimental: Combination Cohorts - 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.


Other interventions: 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.

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Participants will be followed up for up to 6 months.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Microscopic examinations of sample collected at 17weeks after the first dose.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Change in nBCC will be assessed for up to 6 months from the first treatment visit.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
Siller Medical T/A Central Brisbane Dermatology - Brisbane
Recruitment hospital [3] 0 0
Veracity Clinical Research - Brisbane
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ascend Biopharmaceuticals Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02550678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda Spelman
Address 0 0
Veracity Clinical Research Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications