- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04470726
저 위험 기저 세포 암종에 대한 AIV001의 안전성 및 효능 (NMSC)
조직검사로 확진된 기저세포암종 대상자를 대상으로 AIV001 피내투여의 안전성 및 유효성을 평가하기 위한 탐색적 연구
To evaluate safety and efficacy of AIV001 treatment on low-risk Nonmelanoma Skin Caner of the basal cell carcinoma subtype.
연구 개요
상세 설명
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, inflammation, and fibrosis associated with various pathological skin conditions and was formulated as a simple intradermal/intratumoral injection demonstrating prolonged skin residence. Surgical excision is the standard treatment for NMSC of the basal cell carcinoma subtype for lesions of < 20 mm. Surgical removal of lesions is effective but for some patients unwilling or contraindicated for surgery a nonsurgical option is needed. A nonsurgical option will eliminate post-surgical complications and scarring experienced after lesion removal. Also, specific anatomical location of lesions present cosmesis (i.e., face) or healing challenges (i.e., lower limbs). An effective injectable will benefit patients who are averse to surgery, at risk of wound healing complications or concerned with cosmesis outcomes or fatigued from multiple surgeries. Patient populations (i.e., elderly or patients with diabetes) who are at risk of delayed wound healing would benefit from an injectable option. This study will evaluate injection methods, interval of treatment, four ascending doses, safety, histological clearance and clinical clearance of biopsy-confirmed "low-risk" BCC lesion of <20 mm located on non-facial skin.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
California
-
Encinitas, California, 미국, 92024
- California Dermatology & Clinical Research Institute
-
Newport Beach, California, 미국, 92660
- Island Dermatology
-
San Diego, California, 미국, 92117
- Skin Surgery Medical Group
-
-
Texas
-
Pflugerville, Texas, 미국, 78660
- Austin Institute for Clinical Research
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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 Criteria:
- 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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: AIV001 Treatment Dose 1
Intradermal/intratumoral, Dose 1 |
Intradermal/intratumoral AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection |
|
실험적: AIV001 Treatment Dose 2
Intradermal/intratumoral, Dose 2 |
Intradermal/intratumoral AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection |
|
실험적: AIV001 Treatment Dose 3
Intradermal/intratumoral, Dose 3 |
Intradermal/intratumoral AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection |
|
실험적: AIV001 Treatment Dose 4
Intradermal/intratumoral, Dose 4 |
Intradermal/intratumoral AIV001 is administered as a aqueous suspension by an intradermal/intratumoral injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of adverse events during study period
기간: Approximately 119 days
|
Incidence of adverse events |
Approximately 119 days
|
|
Percentage of Histological Clearance achieved of BCC treated lesion
기간: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
|
full clearance is no residual BCC cells by histology |
Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Clinical Clearance of treated basal cell carcinoma lesion on skin surface
기간: Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
|
Number of participants with no surface tumor visible in the study lesion on excision day |
Cohort 1-3 Day 63; Cohort 4 Day 105 or Day 126
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AIV001-C01
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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