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Basal Cell Nevus SyndromePhase 1/2ASN-002-001NCT02550678

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

A Phase 1/2 study testing ASN-002 and 5-FU in people with Basal Cell Nevus Syndrome and Skin Neoplasm, run by Ascend Biopharmaceuticals Ltd at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ASN-002 and 5-FU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesAustralia
Study dates
Sep 2015to Nov 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Siller Medical T/A Central Brisbane Dermatology

    Brisbane, Queensland, 4000

  • Veracity Clinical Research

    Brisbane, Queensland, 4102

  • St George Dermatology and Skin Cancer Centre

    Kogarah, New South Wales, 2217

  • Sinclair Dermatology

    Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FU is safe and effective in the treatment of nodular basal cell carcinoma (nBCC).

Patients aged 18 or over, who have been diagnosed with nodular Basal Cell Carcinoma (nBCC), may be eligible to join this study.

Study details:

ASN-002 is an immunotherapeutic product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body's own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. Participants will attend the study centre weekly for an injection of ASN-002 alone of in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumor.

Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study.

It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone or in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Being tested
ASN-002, 5-FU
Keywords
Untreated nBCC, Low-Risk
Medical subject headings
Basal Cell Nevus Syndrome, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASN-002Biological

    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.

  • 5-FUDrug

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

Study groups in NCT02550678
Study groupRoleWhat they receive
Cohort 1ExperimentalStudy Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.
Receives: Biological: ASN-002
Cohort 2ExperimentalStudy Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks
Receives: Biological: ASN-002
Cohort 4ExperimentalStudy Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Receives: Biological: ASN-002
Cohort 5ExperimentalStudy Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Receives: Biological: ASN-002
Combination CohortsExperimentalStudy 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.
Receives: Biological: ASN-002; Drug: 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants will be followed up for up to 6 months.

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02550678
Sponsor's protocol ID
ASN-002-001
Acronym
ASN-002-001
Status last verified
Jun 2018
First submitted
10 Sep 2015
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASN-002 and 5-FU in people with Basal Cell Nevus Syndrome and Skin Neoplasm, run by Ascend Biopharmaceuticals Ltd at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC (time frame: Participants will be followed up for up to 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02550678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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