A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
2019년 11월 4일 업데이트: Millennium Pharmaceuticals, Inc.
A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Pevonedistat in Patients With Advanced Solid Tumors
The purpose of this study is to assess the mass balance (that is, cumulative excretion of total radioactivity [TRA] in urine and feces) and to characterize the pharmacokinetics (PK) of pevonedistat in whole blood, plasma, and urine, and of TRA in plasma and whole blood following a single 1-hour infusion of 25 milligram per square meter (mg/m^2) [14C]-pevonedistat intravenous (IV) solution containing approximately 60 to 85 microcurie (mCi) (approximately 2.22-3.145
megabecquerel [MBq]) of TRA in participants with advanced solid tumors in Part A.
연구 개요
상태
완전한
상세 설명
The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people with advanced solid tumors.
The study will enroll approximately 4 to 6 pharmacokinetics (PK)-evaluable participants in part A. After completion of the mass balance and absorption, distribution, metabolism, excretion (ADME) assessment in Part A of the study, eligible participants will have the opportunity to continue into Part B at a secondary study site, which would begin in approximately 2 weeks of completion of Part A.
- [14C]-Pevonedistat 25 mg/m^2
- Part B (optional): Pevonedistat in combination with chemotherapy regimens (Pevonedistat 25 mg/m^2 + docetaxel 75 mg/m^2 or pevonedistat 20 mg/m^2 + carboplatin 20 mg/m^2 + paclitaxel 175 mg/m^2)
All participants will receive study drug via intravenous route. This multi-center trial will be conducted in Hungary. Participants will remain confined to the study site for 9 to 14 days in Part A. Participation in Part B is optional, participants will be re-evaluated for inclusion/exclusion criteria before administrating treatment. Participants will undergo treatment in Part B for a maximum of 12 cycles (21 days cycle each) and will include approximately 36 weeks for Part A and B combined. Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B.
연구 유형
중재적
등록 (실제)
8
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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Budapest, 헝가리, 1062
- Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
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Budapest, 헝가리, 1076
- PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with one of the 2 chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel), or have progressed despite prior standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival longer than 3 months from enrollment in the study.
- Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Exclusion Criteria:
- Has irregular defecation patterns (less than 1 defecation per 2 days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes.
- Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: [14C]-Pevonedistat 25 mg/m^2
[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626
MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. After completion of Part A, participants will have opportunity to continue into Part B. Participant will receive Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles along with docetaxel 75 mg/m^2, infusion, intravenously, over 1 hour on Day 1 of each 21 day cycle; or pevonedistat 20 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles, followed by paclitaxel 175 mg/m^2, infusion, intravenously, over 3 hours along with carboplatin 20 mg/m^2, infusion, intravenously, over 30 minutes on Day 1 of 21 each cycle up to 12 cycles.
Based on investigator and sponsor discretion, participants deriving benefits will continue to receive current combination therapy or pevonedistat alone beyond 12 cycles.
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페보네디스타트 정맥주사.
다른 이름들:
도세탁셀 정맥주사.
Carboplatin 정맥 주입.
파클리탁셀 정맥주사.
[14C]-Pevonedistat intravenous infusion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Renal Clearance (CLR) for Pevonedistat
기간: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
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Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
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Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
기간: Up to 168 hours post-dose
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Up to 168 hours post-dose
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Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
기간: Up to Cycle 11 (Cycle length =21 days)
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The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD).
It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm).
PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
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Up to Cycle 11 (Cycle length =21 days)
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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 (실제)
2017년 5월 11일
기본 완료 (실제)
2018년 2월 8일
연구 완료 (실제)
2018년 11월 5일
연구 등록 날짜
최초 제출
2017년 2월 14일
QC 기준을 충족하는 최초 제출
2017년 2월 15일
처음 게시됨 (실제)
2017년 2월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 11월 4일
마지막으로 확인됨
2019년 11월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Pevonedistat-1013
- U1111-1169-6648 (레지스트리 식별자: WHO)
- 2016-004132-37 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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. .