전이성 거세 저항성 전립선암(mCRPC) 치료법의 안전성과 유효성
2026년 8월 4일 업데이트: Amgen
전이성 거세 저항성 전립선암(mCRPC)에 대한 치료법의 안전성과 효능을 평가하는 마스터 프로토콜
이것은 전이성 거세 저항성 전립선암(mCRPC) 참가자의 연구 요법의 안전성과 효능을 평가하기 위해 고안된 마스터 프로토콜입니다.
연구 개요
상태
상태
종료됨
정황
정황
개입 / 치료
개입 / 치료
상세 설명
엔잘루타마이드, 아비라테론 또는 PD1 억제제 AMG 404, AMG 404 단일 요법과 병용한 아카파타맙의 안전성, 내약성, 최대 허용 용량(MTD) 또는 권장 2상 용량(RP2D) 및 효능을 평가하기 위해 설계된 마스터 프로토콜입니다. , 뿐만 아니라 전이성 거세 저항성 전립선암(mCRPC) 참가자의 아카파타맙 단독 요법.
연구 유형
연구 유형
중재적
등록 (실제)
등록
55
단계
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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København Ø, 덴마크, 2100
- Rigshospitalet
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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Orange, California, 미국, 92868
- University of California at Irvine Medical Center
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San Francisco, California, 미국, 94158
- University of California San Francisco Mission Bay Campus
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Kentucky
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Louisville, Kentucky, 미국, 40207
- Norton Cancer Institute
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
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Lund, 스웨덴, 221 85
- Skånes universitetssjukhus
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Stockholm, 스웨덴, 171 76
- Karolinska Universitetssjukhuset Solna
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Uppsala, 스웨덴, 75185
- Akademiska Sjukhuset
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Clinica Universidad de Navarra
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Sutton, 영국, SM2 5PT
- Royal Marsden Hospital
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New South Wales
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Darlinghurst, New South Wales, 호주, 2010
- St Vincents Hospital Sydney
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
모든 부분
포함 기준:
- ≥ 18세(또는 국가 내 법적 성인 연령)
- 피험자는 연구 관련 활동/절차를 시작하기 전에 정보에 입각한 동의를 제공했습니다.
- 조직학적 또는 세포학적으로 확인된 전립선 선암종이 있는 mCRPC 환자
- 피험자는 양측 고환 절제술을 받았거나 성선 자극 호르몬 방출 호르몬 작용제 또는 길항제(테스토스테론 ≤ 50ng/dL(또는 1.7nmol/L))를 사용하여 지속적인 안드로겐 박탈 요법을 받아야 합니다.
제외 기준:
- 중추신경계(CNS) 전이 또는 연수막 질환
- 임상적으로 관련된 CNS 병리의 병력 또는 존재
- 확인된 병력 또는 현재 자가면역질환 또는 영구적인 면역억제 요법이 필요한 기타 질환
- 12개월 이내의 심근경색, 조절되지 않는 고혈압, 불안정 협심증, 약물 치료가 필요한 심장 부정맥 및/또는 증후성 울혈성 심부전(뉴욕 심장 협회 > 클래스 II)
- mCRPC에 대한 탁센 사전 치료
- 4주 이내 대수술 및/또는 방사선
중증급성호흡기증후군 코로나바이러스 2(SARS-CoV-2) 감염 병력 또는 증거는 의료 모니터와 동의하지 않고 다음 기준을 충족하지 않는 한:
- 아카파타맙(또는 파트 3의 AMG 404) 첫 투여 후 72시간 이내 실시간 중합효소연쇄반응(RT-PCR)에 의한 SARS-CoV-2 RNA 음성 검사
- 아카파타맙(또는 3부에서 AMG 404)의 첫 투여 전 10일 이내에 COVID-19 질병의 급성 증상이 없음(무증상 피험자의 경우 양성 검사일부터 계산)
이전/동시 임상 연구 경험
- 현재 다른 조사 장치 또는 약물 연구에서 치료를 받고 있거나 다른 조사 장치 또는 약물 연구(들)에서 치료를 종료한 지 4주 미만입니다. 이 연구에 참여하는 동안 다른 조사 절차는 조사 스캔을 제외하고 제외됩니다.
하위 프로토콜 A 전용:
포함 기준
• mCRPC를 위해 처음으로 엔잘루타마이드를 투여받을 계획인 피험자
제외 기준
- 강력한 CYP2C8 억제제 또는 강력한 CYP3A4 유도제의 사용
- CYP3A4, CYP2C9 또는 CYP2C19의 기질인 좁은 치료 지수 약물의 사용
하위 프로토콜 B 전용:
포함 기준
- mCRPC 제외 기준을 위해 처음으로 아비라테론을 투여받을 계획인 피험자
- 베이스라인 중등도 및 중증 간 장애(Child-Pugh Class B 및 C)
- 조절되지 않는 고혈압, 저칼륨혈증 또는 체액 저류의 존재
- 부신피질 부전의 병력 또는 존재
- 치료 지수가 좁은 CYP2D6에 민감한 기질인 병용 약물의 사용
- 강력한 CYP3A4 유도제 사용
하위 프로토콜 C 전용:
포함 기준
- 새로운 항안드로겐 요법에 불응성인 피험자. 피험자는 탁산 요법에 부적격하거나 거부해야 합니다.
- 1개 이상의 PCWG3 기준으로 정의되는 진행성 질환의 증거: 최소 1주일 간격으로 최소 2회 연속적인 경우에 증가한 PSA 수준 >/=1 ng/mL, PCGW3 변형을 사용한 RECIST 1.1에 의해 정의된 림프절 또는 내장 진행, 및/또는 뼈 스캔에서 2개 이상의 새로운 병변의 출현 제외 기준
- 간질성 폐 질환 또는 활동성 비감염성 폐렴의 병력 또는 증거
- 이전 PD-1 또는 PD-L1 억제제를 복용 중이며 투여 첫날 이전에 3등급 이상의 면역 관련 부작용을 경험한 피험자
하위 프로토콜 D 전용:
포함 기준
- 피험자는 전립선암에 대해 새로운 호르몬 요법(NHT; 예: 아비라테론, 엔잘루타미드, 아팔루타미드 또는 다로루타미드)을 받았을 수 있지만 전이성 전립선암에 대해 1 NHT 이하
- 탁산 요법에 대한 부적격 또는 거부
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
11
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 아카파타맙 및 엔잘루타마이드: 용량 탐색
연구의 용량 탐색 부분에서는 엔잘루타마이드와 병용한 아카파타맙의 MTD/권장 2상 용량(RP2D)을 추정할 것입니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Enzalutamide는 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 엔잘루타마이드: 용량 확장
용량 탐색에 이어 선택된 용량의 안전성과 내약성을 확인하고 아카파타맙과 엔잘루타마이드의 병용 효능을 추가로 평가하기 위해 용량 확장을 실시할 것입니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Enzalutamide는 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 아비라테론: 용량 탐색
연구의 용량 탐색 부분에서는 아비라테론과 병용한 아카파타맙의 MTD/권장 2상 용량(RP2D)을 추정할 것입니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Abiraterone은 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 아비라테론: 용량 확장
용량 탐색에 이어 선택된 용량의 안전성과 내약성을 확인하고 아비라테론과 병용한 아카파타맙의 효능을 추가로 평가하기 위해 용량 확장을 실시할 것입니다.
|
아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Abiraterone은 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 AMG 404: 용량 탐색
연구의 용량 탐색 부분은 AMG 404와 조합된 아카파타맙의 MTD/RP2D를 추정할 것입니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
AMG 404는 정맥(IV) 주입으로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 AMG 404: 용량 확장
용량 탐색에 이어 선택된 용량의 안전성과 내약성을 확인하고 AMG 404와 병용한 아카파타맙의 효능을 추가로 평가하기 위해 용량 확장이 수행될 것입니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
AMG 404는 정맥(IV) 주입으로 투여됩니다.
다른 이름들:
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활성 비교기: AMG 404 단일 요법
AMG 404 단일 요법은 mCRPC 집단에서 PD-1 억제의 예비 항종양 활성을 평가하기 위해 수행되고 있습니다.
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AMG 404는 정맥(IV) 주입으로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 엔잘루타마이드: 용량 확장 아시아 코호트
용량 탐색 후, 용량 탐색에서 결정된 조합 MTD/RP2D에서 아시아 코호트에서 용량 확장을 수행하여 아시아 피험자에 대한 아카파타맙과 엔잘루타마이드의 조합의 안전성, 내약성 및 PK를 확인합니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Enzalutamide는 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 아비라테론: 용량 확장 아시아 코호트
용량 탐색 후, 아시아 피험자에 대해 아카파타맙과 아비라테론의 조합의 안전성, 내약성 및 PK를 확인하기 위해 용량 탐색에서 결정된 조합 MTD/RP2D에서 아시아 코호트에서 용량 확장이 수행될 것이다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
Abiraterone은 구두로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 및 AMG 404: 용량 확장 아시아 코호트
용량 탐색 후, 아시아 피험자에 대한 아카파타맙과 AMG 404 병용의 안전성, 내약성 및 PK를 확인하기 위해 용량 탐색에서 결정된 조합 MTD/RP2D에서 아시아 코호트에서 용량 확장이 수행될 것이다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
AMG 404는 정맥(IV) 주입으로 투여됩니다.
다른 이름들:
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실험적: 아카파타맙 단독 요법
아카파타맙 단일 요법은 mCRPC 환자에서 아카파타맙의 안전성, 내약성, 약동학(PK), 약력학 및 효능을 평가하기 위해 수행되고 있습니다.
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아카파타맙은 정맥내(IV) 주입으로 투여됩니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
기간: Cycle 1: Day 1 to Day 28 (28-day cycle)
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DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including:
The complete list of DLTs are described in the protocol |
Cycle 1: Day 1 to Day 28 (28-day cycle)
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Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
기간: From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
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A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started on or after first dose of investigational product (AMG 160 or AMG 404 for Part 1 and 2; AMG 404 for Part 3). A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab, or AMG 404 (subprotocol C, parts 1 and 2 only). Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
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Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
기간: From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
|
A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
|
|
Subprotocol C, Part 3: Objective Response Rate (ORR)
기간: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
Objective Response is defined as a complete response (CR) or partial response (PR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
|
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
기간: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
|
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
|
Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
기간: Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose assessments of AMG 404 on Cycle 1 Day 1.
|
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
|
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
기간: Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subprotocols A. B, C (Parts 1 and 2) and D: ORR
기간: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Objective Response is defined as a CR or PR per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later.
Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
기간: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement).
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1 > 0.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
기간: From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement.
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
|
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
기간: Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:
The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1. |
Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
기간: From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of CTC0 response was defined as the time from the date of initial CTC0 response to the earlier of CTC0 progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC0 response censored on the date of their last CTC0 or CTC conversion assessment.
|
From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
기간: From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of CTC conversion response was defined as the time from the date of an initial CTC conversion response to the earlier of CTC conversion progression or death.
Participants who had not ended their response at the time of analysis had duration of CTC response censored on the date of their last CTC0 or CTC conversion assessment.
|
From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
기간: From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of PSA response was defined as the time of an initial PSA response (PSA 50) to the earlier of PSA progression or death.
Participants who had not ended their response at the time of analysis had duration of PSA response censored on the date of their last PSA measurement.
|
From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
기간: From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Duration of response per RECIST 1.1 was defined as the time from the date of an initial objective response (CR/PR) per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death.
CR/PR must have been confirmed at least 4 weeks later.
Participants who had not ended their response at the time of analysis had duration of response censored at their last evaluable tumor assessment by computed tomography (CT)/magnetic resonance imaging (MRI) scan.
|
From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
기간: From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
OS was defined as the time from the date of trial Day 1 until death due to any cause.
OS time (months) = (date of death - trial Day 1 + 1) x 12/365.25.
Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Kalbfleisch and Prentice.
|
From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
기간: From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
rPFS was defined as the time from trial Day 1 to radiographic progression.
If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without disease progression (PD) or death recorded, rPFS was censored on the date of the first dose of the investigational product (IP).
rPFS was censored at the last evaluable radiographic tumor assessment date for participants who had no PD, death or new anti-cancer therapy reported, started a new anti-cancer therapy prior to PD or death, if death recorded without new anti-cancer therapy and without PD, if death or PD immediately after more than one consecutively missed tumor assessment occurred.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
기간: From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
PSA PFS was defined as the interval from trial Day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement.
If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or known, PSA PFS was censored at trial Day 1.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
기간: From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Clinical PFS was defined as the time from the first dose to clinical disease progression or death from any cause.
If a participant had no evaluable post-baseline or on-trial disease assessment or was on trial without PD or death recorded, clinical PFS was censored on the date of the first dose of the IP.
Otherwise, clinical PFS was censored on the date of last assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
기간: From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Time to radiographic progression was defined as the interval from Day 1 to radiographic progression in the absence of subsequent anticancer therapy. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without PD or death recorded, time to radiographic progression was censored on the date of the first dose of the IP. Time to radiographic progression was censored on the date of last evaluable radiographic tumor assessment for participants who:
The median was estimated using the Kaplan-Meier method and the 95% CI was estimated using the method by Brookmeyer and Crowley. |
From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
기간: From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Time to PSA progression was defined as the interval from trial Day 1 to PSA progression.
If a participant had no evaluable post-baseline or on-trial PSA assessment, time to PSA progression was censored on the date of the first dose of the IP.
Otherwise, time to PSA progression was censored on the date of the last PSA assessment.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
기간: From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Time to subsequent therapy was defined as the interval from trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy; otherwise, time to subsequent therapy was censored at the last known date of any of the trial assessments prior to initiating the subsequent cancer therapy/subsequent therapy.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Percentage of Participants Who Experienced a Gallium Prostate-specific Membrane Antigen-11 (PSMA-11) Response
기간: Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
A Gallium PSMA-11 response was defined as a ≥ 50% reduction from baseline in the maximum standardized update value (SUV) using 68Gallium (68Ga)-PSMA-11 positron emission tomography (PET)/CT.
PSMA-11 response percentages were based on the number of participants with a baseline PSMA assessment (defined as the last non-missing value on or prior to the pre-dose of acapatamab/AMG 404 assessments) on Cycle 1 Day 1.
The 95% confidence interval was calculated based on the Clopper-Pearson method.
|
Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
기간: From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
Time to symptomatic skeletal events was defined as time from trial Day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of acapatamab/AMG 404 or end of safety follow-up date, whichever was later.
Symptomatic skeletal events included fracture, spinal cord compression and radiation or surgery to bone.
The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
|
From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Total Alkaline Phosphatase Levels
기간: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Alkaline phosphatase levels were collected locally and centrally.
|
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Bone Specific Alkaline Phosphatase Levels
기간: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Bone specific alkaline phosphatase levels were collected locally and centrally.
|
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Lactate Dehydrogenase Levels
기간: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Lactate dehydrogenase levels were collected locally and centrally.
|
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Hemoglobin Levels
기간: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
|
Hemoglobin levels were collected locally.
|
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Neutrophil-to-lymphocyte Ratio
기간: Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
|
Data for the neutrophil-to-lymphocyte ratio were collected locally.
Neutrophil-to-lymphocyte ratio was calculated by dividing the number of absolute neutrophils by the number of lymphocytes.
|
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
|
|
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Urine N-telopeptide Levels
기간: Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
Urine N-telopeptide levels were collected centrally.
|
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
|
|
Subprotocol A, B and C (Parts 1 and 2) and D: Maximum Serum Concentration (Cmax) of Acapatamab
기간: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
Serum concentrations of acapatamab were determined using a validated assay.
|
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
|
Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
기간: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
Serum concentrations of acapatamab were determined using a validated assay.
|
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
|
Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
기간: Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
Serum concentrations of acapatamab were determined using a validated assay.
|
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
|
Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
기간: Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
Serum concentrations of acapatamab were determined using a validated assay.
|
Cycle 2: Days 1 to 14 (each cycle was 28 days)
|
|
Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
기간: From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab. A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab. Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs. |
From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2021년 1월 15일
기본 완료 (실제)
기본 완료
2023년 10월 23일
연구 완료 (실제)
연구 완료
2023년 10월 23일
연구 등록 날짜
최초 제출
최초 제출
2020년 11월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2020년 11월 13일
처음 게시됨 (실제)
처음 게시됨
2020년 11월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 26일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 4일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 20190505
- 2020-001305-23 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
승인된 데이터 공유 요청에서 특정 연구 질문을 해결하는 데 필요한 변수에 대해 식별되지 않은 개별 환자 데이터.
IPD 공유 기간
이 연구와 관련된 데이터 공유 요청은 연구가 종료되고 1) 제품 및 적응증이 미국과 유럽 모두에서 시판 허가를 받았거나 2) 제품 및/또는 적응증에 대한 임상 개발이 중단된 후 18개월부터 고려됩니다. 데이터는 규제 당국에 제출되지 않습니다.
이 연구에 대한 데이터 공유 요청을 제출할 수 있는 자격에 대한 종료 날짜는 없습니다.
IPD 공유 액세스 기준
자격을 갖춘 연구원은 연구 목표, 범위 내 Amgen 제품 및 Amgen 연구/연구, 종점/관심 결과, 통계 분석 계획, 데이터 요구 사항, 출판 계획 및 연구원 자격을 포함하는 요청을 제출할 수 있습니다.
일반적으로 Amgen은 제품 라벨링에서 이미 언급된 안전성 및 효능 문제를 재평가할 목적으로 개별 환자 데이터에 대한 외부 요청을 허용하지 않습니다.
요청은 내부 고문 위원회에서 검토합니다.
승인되지 않은 경우 데이터 공유 독립 검토 패널이 중재하고 최종 결정을 내립니다.
승인되면 연구 질문을 해결하는 데 필요한 정보가 데이터 공유 계약 조건에 따라 제공됩니다.
여기에는 익명화된 개별 환자 데이터 및/또는 분석 사양에 제공된 분석 코드의 일부를 포함하는 사용 가능한 지원 문서가 포함될 수 있습니다.
자세한 내용은 아래 URL에서 확인할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .