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A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma (ASN-002-001)

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ClinicalTrials.gov Identifier: NCT02550678
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ascend Biopharmaceuticals Ltd

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.


Condition or disease Intervention/treatment Phase
Basal Cell Nevus Syndrome Skin Neoplasm Nodular Basal Cell Carcinoma of Skin Biological: ASN-002 Drug: 5-FU Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


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

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
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.

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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. Microscopic clearance of the injected basal cell carcinoma. [ Time Frame: Microscopic examinations of sample collected at 17weeks after the first dose. ]
    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.

  2. Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU [ Time Frame: Change in nBCC will be assessed for up to 6 months from the first treatment visit. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550678


Locations
Australia, New South Wales
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Siller Medical T/A Central Brisbane Dermatology
Brisbane, Queensland, Australia, 4000
Veracity Clinical Research
Brisbane, Queensland, Australia, 4102
Australia, Victoria
Sinclair Dermatology
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Ascend Biopharmaceuticals Ltd
Investigators
Principal Investigator: 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

Responsible Party: Ascend Biopharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT02550678     History of Changes
Other Study ID Numbers: ASN-002-001
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ascend Biopharmaceuticals Ltd:
Untreated nBCC
Low-Risk

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Basal Cell Nevus Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn