CompletedPhase 1/2

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

Australia16 participantsStarted 2015-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidences of ASN-002 related Adverse Event in patients with previously untreated nBCC

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

Trial details

NCT IDNCT02550678

SponsorAscend Biopharmaceuticals Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11

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