CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
ASN-002 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02550678
NCT02550678Phase 2Completed
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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

Ascend Biopharmaceuticals Ltd·interventional·Posted Sep 15, 2015·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating ASN-002 and 5-FU for Basal Cell Nevus Syndrome and 2 related conditions. Completed, enrolled 16 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Nevus Syndrome, Skin Neoplasm, Nodular Basal Cell Carcinoma of Skin
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartSep 1, 2015
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.8 years ago

Interventions

ASN-002biological

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-FUdrug

5-FU is chemotherapeutic agent used to treat various cancers.