The safety and scientific validity of each study registered on the ANZCTR is the responsibility of the study sponsor and investigators. Listing a study on the ANZCTR does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to information for consumers

Number of records retrieved: 2



Page: 1 

Trial from ANZCTR

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

  • Recruitment status at the time of last update
    Active, not recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 26/3/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615001017516

Date registered

29 September 2015

Health condition

Nodular Basal Cell Carcinoma, Basal Cell Carcinoma Nevus Syndrome

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland, Victoria

Recruitment status

Active, not recruiting

Anticipated date of first participant enrolment

15 September 2015

Ethics application status

Approved

Brief summary

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

Who is it for?
You may be eligible to join this study if you are aged 18 or over, have been diagnosed with nBCC.

Study details
ASN-002 is a vaccine-like 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. 5-FU is a chemotherapeutic agent approved to treat many types of cancer. Participants will attend the study centre weekly for an injection of ASN-002 alone or 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 tumour.
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 and in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

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

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 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.

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: Ascend Biopharmaceutical Ltd.
Address: Level 1, 159 Dorcas Street
South Melbourne VIC 3205
Country: Australia

Contact person for information and recruitment

Dr Clement Leong
Ascend Biopharmaceuticals Ltd
Level 1, 159 Dorcas Street
South Melbourne VIC 3205
Australia
+61 3 86063400
clementleong@ascendbiopharma.com



Trial from ClinicalTrials.gov

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

  • Recruitment status at the time of last update
    Completed
  • Has the trial been updated in the last 24 months?
    Up to date
    (Last updated: 3/6/2018)
Key trial Information

Trial ID

NCT02550678

Date registered

14 September 2015

Recruitment status

Completed

Anticipated date of first participant enrolment

n/a

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.

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

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.