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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)

Primary Purpose

Basal Cell Nevus Syndrome, Skin Neoplasm, Nodular Basal Cell Carcinoma of Skin

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ASN-002
5-FU
Sponsored by
Ascend Biopharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Nevus Syndrome focused on measuring Untreated nBCC, Low-Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St George Dermatology and Skin Cancer Centre
  • Siller Medical T/A Central Brisbane Dermatology
  • Veracity Clinical Research
  • Sinclair Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 4

Cohort 5

Combination Cohorts

Arm Description

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

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

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 10, 2015
Last Updated
June 3, 2018
Sponsor
Ascend Biopharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02550678
Brief Title
A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
Acronym
ASN-002-001
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascend Biopharmaceuticals Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Nevus Syndrome, Skin Neoplasm, Nodular Basal Cell Carcinoma of Skin
Keywords
Untreated nBCC, Low-Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Study Participants will receive ASN- 002 at a dose of 2.25X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Arm Title
Combination Cohorts
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ASN-002
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
5-FU is chemotherapeutic agent used to treat various cancers.
Primary Outcome Measure Information:
Title
Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC
Description
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.
Time Frame
Participants will be followed up for up to 6 months.
Secondary Outcome Measure Information:
Title
Microscopic clearance of the injected basal cell carcinoma.
Description
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.
Time Frame
Microscopic examinations of sample collected at 17weeks after the first dose.
Title
Clinical Changes in size of nBCC tumor over time after treatment with ASN-002 alone or in combination with 5-FU
Description
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.
Time Frame
Change in nBCC will be assessed for up to 6 months from the first treatment visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low risk nodular basal cell carcinoma Biopsy of any other skin tumor Willingness to have injection therapy followed by surgery Written informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Spelman
Organizational Affiliation
Veracity Clinical Research Pty Ltd.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodney Sinclair
Organizational Affiliation
Sinclair Dermatology Pty Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Siller
Organizational Affiliation
Siller Medical T/A Central Brisbane Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George Dermatology and Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Siller Medical T/A Central Brisbane Dermatology
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Veracity Clinical Research
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Sinclair Dermatology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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