Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma
2017년 1월 23일 업데이트: Janssen Pharmaceutical K.K.
A Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
The purpose of this study is to evaluate overall response rate (ORR) (complete response [CR] rate plus partial response [PR] rate) of ibrutinib (IMBRUVICA™; PCI-32765; JNJ-54179060), as assessed by an Independent Review Committee (IRC), in participants with relapsed or refractory mantle cell lymphoma (MCL-a cancer of the lymph nodes or tissues).
연구 개요
상세 설명
This is a Phase 2, single-arm, open-label (all knew the intervention of study), and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to explore the efficacy, safety and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of ibrutinib in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) MCL.
The study will consist of a Screening Phase of 30 days prior to first dose of study drug followed by treatment Phase and a post-treatment follow-up Phase.
Participants will receive ibrutinib 560 milligram (mg) orally, once daily on a 28-day cycle until disease progression (or relapse if the participant achieved a CR), unacceptable toxicity, or study end, whichever occurs first.
Treatment Phase will have disease assessments every 8 weeks up to 24 weeks after start of study drug, then every 12 weeks thereafter to assess efficacy up to 2 years after last participant enrolled.
Efficacy will primarily be evaluated by ORR.
Participants' safety will be monitored throughout the study.
연구 유형
중재적
등록 (실제)
16
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fukuoka, 일본
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Isehara, 일본
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Kobe, 일본
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Kyoto, 일본
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Nagoya, 일본
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Osaka, 일본
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Sendai, 일본
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Tokyo, 일본
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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
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of mantle cell lymphoma ( MCL) must include morphology and expression of either cyclin D1 in association with one B-cell marker (for example, cluster of differentiation [CD] CD19, CD20, or paired box [PAX5]) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
- Received at least 1 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- At least 1 measurable site of disease according to the Revised Response Criteria for Malignant Lymphoma (that is, the site of disease must be greater than 1.5 centimeter [cm] in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions)
- Have documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent anti-MCL treatment regimen
- Eastern Cooperative Oncology Group performance status score of 0 or 1
Exclusion Criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
- Prior treatment with ibrutinib or other Bruton's Tyrosine Kinase (BTK) inhibitors
- More than 5 prior lines of therapy for MCL (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval)
- Known central nervous system (CNS) lymphoma
- Woman who is pregnant, breast-feeding, or planning to become pregnant within 1 month after the last dose of study drug or is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ibrutinib
Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
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Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Overall Response
기간: Up to 2 years after last participant enrolled
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Overall response is defined as achievement of complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC), based on the Revised Response Criteria for Malignant Lymphoma.
CR is: a) disappearance of all detectable disease symptoms and signs; b) lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size; c) negative positron emission tomography (PET) scan; d) normal sized spleen or liver if enlarged before therapy; d) bone marrow infiltrate must be cleared if would have been involved before treatment; e) no new sites of disease.
PR is: a) greater than 50 percent decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, splenic and hepatic nodules; b) no increase in the size of other nodes, liver, or spleen, c) no measurable disease in other organs; d) no new sites of disease; e) 1 PET-positive site of disease (required for the CT+PET assessment of PR).
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Up to 2 years after last participant enrolled
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of Response
기간: Up to 2 years after last participant enrolled
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Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
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Up to 2 years after last participant enrolled
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Time to Response
기간: Up to 2 years after last participant enrolled
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Time to response is the time from the date of first dose of study drug until the first date of initial documentation of a response (CR or PR).
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Up to 2 years after last participant enrolled
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Overall Survival (OS)
기간: Up to 2 years after last participant enrolled
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The OS is defined as the time from the date of first dose of study drug to date of death from any cause.
If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
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Up to 2 years after last participant enrolled
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Progression-free Survival (PFS)
기간: Up to 2 years after last participant enrolled
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The PFS is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
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Up to 2 years after last participant enrolled
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
기간: Day 1 up to 30 days after last dose administration
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An AE is any untoward medical occurrence in a participant who will receive 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; or congenital anomaly.
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Day 1 up to 30 days after last dose administration
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Area Under the Plasma Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
기간: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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The AUC (0-last) is the area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
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Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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Apparent Clearance (CL/F)
기간: Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration.
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Predose (0), 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and 2
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Minimum Observed Plasma Concentration (Cmin)
기간: Predose (0) and 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and Cycle 2
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Minimum Observed Plasma Concentration (Cmin) will be observed.
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Predose (0) and 1, 2, and 4 hours postdose on Day 1 of Cycle 1 and Cycle 2
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2014년 8월 1일
기본 완료 (실제)
2016년 11월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2014년 6월 19일
QC 기준을 충족하는 최초 제출
2014년 6월 20일
처음 게시됨 (추정)
2014년 6월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2017년 1월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 1월 23일
마지막으로 확인됨
2017년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CR104615
- PCI-32765MCL2002 (기타 식별자: Janssen Pharmaceutical K.K., Japan)
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