TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
2023年2月6日 更新者：Calithera Biosciences, Inc
Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy
The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.
研究概览
详细说明
The drug being tested is TAK-659. This study will evaluate overall response rate (ORR) in participants with relapsed or refractory DLBCL who take TAK-659.
The study will enroll approximately 122 participants. Participants will be assigned to:
• TAK-659 60 mg to 100 mg
All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study in a 28-day cycle.
This multi-center trial will be conducted in the United States, United Kingdom, Spain, Italy, France, Canada, Germany. The overall time to participate in this study is approximately 48 months. Participants will be assessed for disease response and progression during the PFS follow-up every 3 months after end of treatment (for participants who discontinue due to reasons other than disease progression) and OS follow-up every 3 months from the last dose of study drug until death or conclusion of the study, whichever occurs first.
研究类型
介入性
注册 (实际的)
49
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec、加拿大、G1J 1Z4
- CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus
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Ontario
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Toronto、Ontario、加拿大、M5G2M9
- Princess Margaret Cancer Center
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Quebec
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Rimouski、Quebec、加拿大、G5L 5T1
- Centre Hospitalier Regional De Rimouski
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Bergamo、意大利、24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Milano、意大利、20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Novara、意大利、28100
- Azienda Ospedaliero-Universitaria "Maggiore della Carità"
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Udine、意大利、33100
- Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
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Foggia
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San Giovanni Rotondo、Foggia、意大利、71013
- Ospedale Casa Sollievo della Sofferenza
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Piemonte
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Torino、Piemonte、意大利、10126
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Aquitaine
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Pessac Cedex、Aquitaine、法国、33604
- Hôpital Haut-Lévêque
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Auvergne
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Clermont-Ferrand、Auvergne、法国、63000
- CHRU Clermont- Ferrand CHU Estaing
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Haute-normandie
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Rouen Cedex 1、Haute-normandie、法国、76038
- Centre Henri-Becquerel
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Ile-de-france
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Paris、Ile-de-france、法国、75015
- Hôpital Necker-Enfants Malades
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Paris Cedex 10、Ile-de-france、法国、75475
- Hopital saint Louis
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Paris Cedex 13、Ile-de-france、法国、75651
- Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere
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Villejuif Cedex、Ile-de-france、法国、94805
- Institut Gustave Roussy
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Limousin, Lorraine
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Limoges Cedex、Limousin, Lorraine、法国、87042
- Hôpital Dupuytren
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Provence Alpes COTE D'azur
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Marseille、Provence Alpes COTE D'azur、法国、13009
- Institut Paoli Calmettes Departement de Recherche Clinique et de l'Innovation
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Rhone-alpes
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Pierre Benite Cedex、Rhone-alpes、法国、69495
- Centre Hospitalier Lyon Sud
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Kansas
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Westwood、Kansas、美国、66205
- University of Kansas Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48109-1274
- University of Michigan
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New York
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Buffalo、New York、美国、14263
- Roswell Park Cancer Institute
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New York、New York、美国、10016
- New York University Langone Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Perelman Center for Advanced Medicine
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Washington
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Edmonds、Washington、美国、98026
- Swedish Medical Oncology - Edmonds
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Issaquah、Washington、美国、98029
- Swedish Cancer Institute - Issaquah
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Seattle、Washington、美国、98104
- Swedish Health Services
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Seattle、Washington、美国、98109
- University of Washington, Hutchinson Cancer Research Center
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Seattle、Washington、美国、98122
- Swedish First Hill Campus
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England
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Birmingham、England、英国、B15 2GW
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
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Harrow、England、英国、HA1 3UJ
- London North West Healthcare NHS Trust, Imperial College London
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London、England、英国、NW1 2BU
- University College London Hospitals Nhs Foundation Trust
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Manchester、England、英国、M20 4BX
- The Christie NHS Foundation Trust
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Newcastle upon Tyne、England、英国、NE7 7DN
- Newcastle Hospitals NHS Foundation Trust
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Barcelona、西班牙、08036
- Hospital Clinic de Barcelona
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28009
- Hospital General Universitario Gregorio Marañon
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Salamanca、西班牙、37007
- Hospital Universitario de Salamanca
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Santander、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
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Valencia、西班牙、46026
- Hospital Universitario la Fe
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、OLDER_ADULT)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL.
a. High-grade B-cell lymphoma (BCL) with MYC and BCL-2 and/or BCL-6 translocations (double-hit DLBCL under DLBCL, not otherwise specified [NOS], based on the 2008 World Health Organization [WHO] classification criteria) is not eligible for this study.
- Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
- Relapsed or refractory to greater than or equal to (>=) 2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
- Documented investigator-assessed relapse or progression after the last treatment is required if the participant responded and then progressed on the prior treatment.
- Measurable disease per IWG 2007 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status less than (<) 2.
- Life expectancy of greater than (>) 3 months.
Adequate organ function, including the following:
- Bone marrow reserve: absolute neutrophil count (ANC) >=1000/microliter (μL), platelet count >=75,000/μL (>=50,000/μL for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL).
- Hepatic: total bilirubin less than or equal to (<=) 1.5 times the upper limit of the normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5*ULN.
- Renal: creatinine clearance >=60 milliliter per minute (mL/min).
Others:
- Lipase <=1.5*ULN and amylase <=1.5*ULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
- Blood pressure <=Grade 1 (hypertensive participants are permitted if their blood pressure is controlled to <=Grade 1 by hypertensive medications.
- Glycosylated hemoglobin is <=6.5% hyperglycemic participants permitted if glucose is well controlled by antihyperglycemic medication).
Exclusion Criteria:
- Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases.
- Known human immunodeficiency virus (HIV)-related malignancy.
- Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment (<=4 weeks for antibody-based therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell engager agents; <=8 weeks for cell-based therapy or anti-tumor vaccine).
- Radiotherapy less than 3 weeks before the first dose of study treatment. If prior radiotherapy occurred <4 to 6 weeks before study start, as radiated lesions cannot be reliably assessed by fluorodeoxyglucose-positron emission tomography (FDG-PET), nonradiated target lesions are required for eligibility, and prior radiotherapy information must be submitted to the IRC.
- Known HIV positive, hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
- Prior autologous stem cell transplant (ASCT) within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
- Participants with certain cardiovascular conditions are excluded.
- Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
- Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
- Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
- Participants with another malignancy within 2 years of study start. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
- Received medications, supplements, or food/beverages that are P-glycoprotein (P-gp) inhibitors or inducers or strong cytochrome P450 (CYP) 3A inhibitors or inducers within a certain timeframe prior to the first dose of study drug. Depending on the substance, the washout period for P-gp inhibitors or inducers or strong CYP3A inhibitors or inducers will be either 7 days or 5 times the half-life (half-life is related to the time required for elimination from the body). The washout period for grapefruit containing food or beverages is 5 days.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：平行线
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cohort A: TAK-659 100 mg
TAK-659 100 mg tablet, orally, once daily (QD), during each 28-days cycle (median exposure was 41 days).
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TAK-659 片剂
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实验性的：Cohort B: TAK-659 Ramp-up Dosing
TAK-659 60-100 mg tablet, orally, QD, dose based on safety and tolerability during each 28-days cycle (median exposure was 28 days).
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TAK-659 片剂
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
大体时间：Up to 12 months
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ORR was defined as the percentage of participants with complete response (CR), or partial response (PR) as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
|
Up to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
大体时间：Up to 12 months
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CR rate was defined as percentage of participants with complete response as assessed by IRC according to the modified 2007 IWG.
CR was defined as disappearance of all evidence of disease.
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Up to 12 months
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Stage 2: ORR as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
大体时间：Up to 12 months
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ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the 2014 Lugano classification, IWG criteria for malignant lymphoma.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
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Up to 12 months
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Stage 2: CR Rate as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
大体时间：Up to 12 months
|
CR rate was defined as percentage of participants with complete response as assessed by IRC according to the 2014 Lugano classification, IWG criteria.
CR was defined as disappearance of all evidence of disease.
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Up to 12 months
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Stage 2: Duration of Response (DOR)
大体时间：Up to 12 months
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DOR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or progressive disease (PD) per IRRC assessment according to IWG criteria.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
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Up to 12 months
|
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Stage 2: Duration of CR
大体时间：Up to 12 months
|
Duration of CR was defined as the time from the date of first documentation of a CR/PR to the date of first documentation of tumor progression or PD per IRRC assessment according to IWG criteria.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
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Up to 12 months
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Stage 2: ORR as Assessed by IRRC in Participants With Germinal Center B-cell (GCB) DLBCL
大体时间：长达 12 个月
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ORR was defined as the percentage of participants with CR or PR as assessed by IRRC according to the modified 2007 IWG criteria for malignant lymphoma.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
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长达 12 个月
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Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
大体时间：Up to 12 months
|
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
|
Up to 12 months
|
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Stage 2: Progression Free Survival (PFS) as Assessed by IRC
大体时间：Up to 18 months
|
PFS was defined as time from start of study treatment to first documentation of PD per IRC assessment or up to death due to any cause, whichever occurs first based on IWG criteria.
PD was defined as presence of any new lesion or increase by >=50% of previously involved sites from nadir.
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Up to 18 months
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Stage 2: Overall Survival (OS)
大体时间：Up to 24 months
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OS was defined as the time from start of study treatment to date of death due to any cause.
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Up to 24 months
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Stage 1: ORR as Assessed by IRRC to Select Stage 2 Dose Regimen of TAK-659 From the Lead-in Dose Exploration Phase
大体时间：Up to 12 months
|
ORR was defined as the percentage of participants with CR or PR as assessed by IRC.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
|
Up to 12 months
|
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Stage 2: ORR as Assessed by IRC at 3, 6, and 9 Cycles in Participants With DLBCL
大体时间：At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)
|
ORR was defined as the percentage of participants with CR or PR as assessed by IRC according to the modified 2007 IWG criteria for malignant lymphoma.
CR was defined as disappearance of all evidence of disease.
PR was defined as regression of measurable disease and no new sites.
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At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月10日
初级完成 (实际的)
2019年12月17日
研究完成 (实际的)
2019年12月17日
研究注册日期
首次提交
2017年4月17日
首先提交符合 QC 标准的
2017年4月20日
首次发布 (实际的)
2017年4月21日
研究记录更新
最后更新发布 (实际的)
2023年2月8日
上次提交的符合 QC 标准的更新
2023年2月6日
最后验证
2023年2月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- C34004
- U1111-1187-6208 (其他：WHO)
- 2016-003716-12 (EUDRACT_NUMBER 个)
- 17/YH/0181 (注册表：NRES)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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