진행성 유방암 여성에서 Camizestrant와 Atirmociclib 병용 요법의 안전성과 내약성을 평가하는 연구 (SERENA-1b)
ER 양성, HER2 음성 진행성 유방암 환자에서 카미제스트란트와 아티르모시클리브 병용 요법의 안전성, 약동학 및 예비 효능을 평가하기 위한 2a상 개방형 연구(SERENA-1b)
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.
연구 개요
상세 설명
This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.
The single-arm study includes:
- Screening period
- Atirmociclib single dose period
- Doublet intervention period
- Post-treatment follow-up period
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63108
- 모병
- Research Site
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Rhode Island
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East Providence, Rhode Island, 미국, 02915
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- Research Site
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Tennessee
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Nashville, Tennessee, 미국, 37203
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- Research Site
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Cambridge, 영국, CB2 0QQ
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- Research Site
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London, 영국, EC1M6BQ
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- Research Site
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Manchester, 영국, M20 4GJ
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- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Main Inclusion Criteria:
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Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.
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Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.
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Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.
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At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.
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Menopausal status
- Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
- Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels.
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Histological or cytological confirmation of adenocarcinoma of the breast.
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Participants of childbearing potential must agree to use one highly effective contraceptive measure.
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Documentation of ER-positive tumor irrespective of progesterone receptor status.
Main Exclusion Criteria:
- A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
- A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
- Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
- Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
- Inability to swallow oral medications.
- Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
- Presence of life-threatening metastatic visceral disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Camizestrant + Atirmociclib
Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1. |
Camizestrant will be administered orally. Atirmociclib will be administered orally. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with adverse events (AEs) and serious AEs
기간: Up to Post-Treatment Follow up (Day 30 Post Dose)
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To investigate the safety and tolerability of camizestrant in combination with atirmociclib. |
Up to Post-Treatment Follow up (Day 30 Post Dose)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum concentration observed (Cmax)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Time to reach maximum (peak) plasma concentration following drug administration (tmax)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Terminal elimination rate constant (λz)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Terminal elimination half-life (t½λz)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent total body clearance (CL/F)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent volume of distribution at steady state (Vss/F)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent volume of distribution based on the terminal phase (Vz/F)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Maximum concentration observed at steady state (Cssmax)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval (AUC0-tau)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Time to reach maximum plasma concentration at steady state (tssmax)
기간: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Objective Response Rate (ORR)
기간: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Duration of Response (DOR)
기간: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Clinical Benefit Rate at 24 Weeks (CBR24)
기간: At 24 weeks
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 24 weeks
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Percentage change in tumor size
기간: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Progression Free Survival (PFS)
기간: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Progression-free survival landmark 6 months (PFSLM6m)
기간: At 6 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 6 months
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Progression-free survival landmark 12 months (PFSLM12m)
기간: At 12 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 12 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- D853CC00001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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