A Phase 1/2 interventional study of ASN-002 and 5-FU in Basal Cell Nevus Syndrome, Skin Neoplasm and Nodular Basal Cell Carcinoma of Skin, sponsored by Ascend Biopharmaceuticals Ltd. Completed at 4 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Ascend Biopharmaceuticals Ltd · Phase 1/2, Interventional, and Treatment
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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.
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.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
This study's enrollment of 16 is below the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Browse Basal Cell Nevus Syndrome studies →Ascend Biopharmaceuticals Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.
Biological: ASN-002
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
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
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
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 · Drug: 5-FU
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-FU is chemotherapeutic agent used to treat various cancers.
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.
Time frame: Participants will be followed up for up to 6 months.
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.
Time frame: Microscopic examinations of sample collected at 17weeks after the first dose.
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.
Time frame: Change in nBCC will be assessed for up to 6 months from the first treatment visit.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Nov 2017, 26 months.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gusacitinib
Ascend Biopharmaceuticals Ltd