Status:
COMPLETED
Safety and Efficacy Evaluation of AIV001 in Nonmelanoma Skin Cancer of the Low Risk Basal Cell Carcinoma Subtype
Lead Sponsor:
AiViva BioPharma, Inc.
Conditions:
Superficial Basal Cell Carcinoma
Nodular Basal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.
Detailed Description
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients with nonmelanoma skin cancer (NMSC) of the basal cell carcinoma (BCC) subtype. AIV001 targets angiogenesis...
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 80 years, inclusive
- No clinically relevant abnormalities identified by a detailed medical history and vital signs
- Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk
- Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1
- No other dermatological disease within 50 mm of the target lesion at Day 1
- No prior or concurrent treatment of the target lesion (including radiation therapy)
- Willing to undergo surgical excision approximately 63 days after first treatment.
Exclusion
- History or presence of systemic cancer
- Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years
- Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)
- Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results.
- History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
- History of recurrence or presence of any other tumor subtype in the target lesion
- Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study
- Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study
- Evidence of dermatological disease or confounding dermatological condition that would hinder carrying out the study or interpreting the results (eg, atopic dermatitis, eczema, psoriasis, xeroderma pigmentosa, etc.)
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04470726
Start Date
August 18 2020
End Date
July 28 2023
Last Update
December 27 2024
Active Locations (4)
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1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
2
Island Dermatology
Newport Beach, California, United States, 92660
3
Skin Surgery Medical Group
San Diego, California, United States, 92117
4
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660