A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-101556143, a Regulated Induced Proximity Targeting Chimera (RIPTAC™) Therapeutic Plus Best Supportive Care Versus Best Supportive Care in Participants With Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer
The purpose of this study is to evaluate how well JNJ-101556143 plus Best Supportive Care (BSC) improves overall survival (the length of time a participant remains alive) compared with placebo plus BSC in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR). mAPMR is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments designed to block male hormones (androgens).
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed
- Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically [bilateral orchiectomy] or with medication)
- Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access
- Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog [agonist or antagonist]) with castrate level of serum testosterone (less than [<] 50 nanograms per deciliter [ng/dL] or 1.7 nanomoles per liter [nmol/L]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase
- Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) non-sponsor investigational drugs within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177^Lu PSMA-617) within 4 weeks prior to randomization and may not have participated in an investigational trial within the sponsor's development program within 6 months prior to randomization
- Toxicity related to prior anticancer treatment that is deemed clinically relevant must have resolved to common terminology criteria for adverse events (CTCAE) Version 6.0 Grade 1 or better
Exclusion Criteria:
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
- Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients
- Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention
- Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Solid organ or bone marrow transplantation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: JNJ-101556143 + Best Supportive Care
Participants will receive JNJ-101556143 orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met. |
Participants will receive JNJ-101556143 orally. Best supportive care may include palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and clinically indicated palliative procedures. |
|
위약 비교기: Placebo + Best Supportive Care
Participants will receive matching placebo orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met. |
Participants will receive matching placebo orally. Best supportive care may include palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and clinically indicated palliative procedures. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to 21 months
|
OS is defined as the time from randomization to date of death from any cause. |
Up to 21 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Radiographic Progression-Free Survival (rPFS)
기간: Up to 21 months
|
rPFS is defined as the time from the date of randomization until the date of radiographic disease progression or death, whichever comes first as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and Prostate Cancer Working Group 4 (PCWG4) criteria. |
Up to 21 months
|
|
Progression-Free Survival (PFS)
기간: Up to 21 months
|
PFS is defined as the time from randomization until disease progression or death, whichever occurs first. |
Up to 21 months
|
|
Time to Symptomatic Progression (TSP)
기간: Up to 21 months
|
TSP is defined as the time from the date of randomization to the date of the first occurrence of any of the following: The use of external beam radiation for palliative treatment; need for tumor-related orthopedic surgical intervention; other cancer-related procedures; cancer-related morbid events and initiation of a new systemic anticancer therapy because of cancer symptoms. |
Up to 21 months
|
|
Time to Skeletal-Related Events (TSRE)
기간: Up to 21 months
|
TSRE is defined as the time from the date of randomization to the date of the first occurrence of any of the following (whichever occurs first):
|
Up to 21 months
|
|
Time to Pain Progression (TTPP)
기간: Up to 21 months
|
TTPP is defined as the time from the date of randomization to first observation of pain progression. Pain progression is defined as an increase of >=2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations >=3 weeks apart with no decrease in analgesic dose. |
Up to 21 months
|
|
Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
기간: Up to 21 months
|
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 21 months
|
|
Number of Participants with Abnormalities in Clinical Laboratory Tests
기간: Up to 21 months
|
Participants with abnormalities in clinical laboratory tests will be reported. |
Up to 21 months
|
|
Plasma Concentration of JNJ-101556143
기간: Pre-dose for Cycles 1 to 4; 2 to 3 hours and 4 to 8 hours Post-dose from Cycles 1 to 2 (each cycle duration is 28 days)
|
Plasma samples will be analyzed to determine concentrations of JNJ-101556143 using a validated LC-MS/MS method. |
Pre-dose for Cycles 1 to 4; 2 to 3 hours and 4 to 8 hours Post-dose from Cycles 1 to 2 (each cycle duration is 28 days)
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 101556143PCR3001
- 101556143PCR3001 (기타 식별자: Janssen Research & Development, LLC)
- 2026-527547-18-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .