Basal Cell Carcinoma in Basal Cell Nevus Syndrome Clinical Trial
Official title:
Phase IIb Open-label Trial of SUBA™-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)
The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome.
Single arm, phase IIb, multi-center, open-label study evaluating the use of oral SUBA-Cap in
subjects with Basal Cell Carcinoma Nevus Syndrome and non-metastatic Basal Cell Carcinoma.
Following informed consent, subjects will undergo a skin biopsy for Gli1 analysis and an
assessment of extent of disease using both tumor measurements (using modified Response
Evaluation Criteria in Solid Tumors criteria) and color photographs of the skin.
Subjects will receive daily oral SUBA-Cap, at a starting dose of 150 mg twice daily (BID).
Reassessments of disease will be conducted at weeks 4, 8, 16, and then every 8 weeks
thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at
least 4 weeks later for confirmation. Subjects may continue to receive SUBA-Cap until disease
progression (defined as the appearance of one or more new lesions or ulceration of a target
lesion) that requires a change in therapy (surgical intervention or use of other systemic
therapy) or the appearance of unacceptable side effects. Pharmacokinetic assessments (serial
trough levels) will be performed at defined intervals and, when possible, prior to and
following any dose adjustment. Skin biopsies will be taken for Gli1 expression at defined
intervals.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT03208296 -
Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)
|
Phase 1/Phase 2 |