TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
6 февраля 2023 г. обновлено: 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.
Обзор исследования
Статус
Прекращено
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
49
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Barcelona, Испания, 08036
- Hospital Clinic de Barcelona
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Barcelona, Испания, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Испания, 28046
- Hospital Universitario La Paz
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Madrid, Испания, 28009
- Hospital General Universitario Gregorio Marañon
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Salamanca, Испания, 37007
- Hospital Universitario de Salamanca
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Santander, Испания, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, Испания, 46026
- Hospital Universitario la Fe
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Bergamo, Италия, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Milano, Италия, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Novara, Италия, 28100
- Azienda Ospedaliero-Universitaria "Maggiore della Carità"
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Udine, Италия, 33100
- Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
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Foggia
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San Giovanni Rotondo, Foggia, Италия, 71013
- Ospedale Casa Sollievo della Sofferenza
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Piemonte
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Torino, Piemonte, Италия, 10126
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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Quebec, Канада, G1J 1Z4
- CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus
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Ontario
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Toronto, Ontario, Канада, M5G2M9
- Princess Margaret Cancer Center
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Quebec
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Rimouski, Quebec, Канада, G5L 5T1
- Centre Hospitalier Regional De Rimouski
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England
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Birmingham, England, Соединенное Королевство, B15 2GW
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
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Harrow, England, Соединенное Королевство, HA1 3UJ
- London North West Healthcare NHS Trust, Imperial College London
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London, England, Соединенное Королевство, NW1 2BU
- University College London Hospitals NHS Foundation Trust
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Manchester, England, Соединенное Королевство, M20 4BX
- The Christie NHS Foundation Trust
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Newcastle upon Tyne, England, Соединенное Королевство, NE7 7DN
- Newcastle Hospitals NHS Foundation Trust
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Kansas
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Westwood, Kansas, Соединенные Штаты, 66205
- University of Kansas Medical Center
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109-1274
- University of Michigan
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New York
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Buffalo, New York, Соединенные Штаты, 14263
- Roswell Park Cancer Institute
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New York, New York, Соединенные Штаты, 10016
- New York University Langone Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Perelman Center For Advanced Medicine
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Washington
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Edmonds, Washington, Соединенные Штаты, 98026
- Swedish Medical Oncology - Edmonds
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Issaquah, Washington, Соединенные Штаты, 98029
- Swedish Cancer Institute - Issaquah
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Seattle, Washington, Соединенные Штаты, 98104
- Swedish Health Services
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Seattle, Washington, Соединенные Штаты, 98109
- University of Washington, Hutchinson Cancer Research Center
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Seattle, Washington, Соединенные Штаты, 98122
- Swedish First Hill Campus
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Aquitaine
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Pessac Cedex, Aquitaine, Франция, 33604
- Hôpital Haut-Lévêque
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Auvergne
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Clermont-Ferrand, Auvergne, Франция, 63000
- CHRU Clermont- Ferrand CHU Estaing
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Haute-normandie
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Rouen Cedex 1, Haute-normandie, Франция, 76038
- Centre Henri-Becquerel
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Ile-de-france
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Paris, Ile-de-france, Франция, 75015
- Hôpital Necker-Enfants Malades
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Paris Cedex 10, Ile-de-france, Франция, 75475
- Hopital Saint Louis
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Paris Cedex 13, Ile-de-france, Франция, 75651
- Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere
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Villejuif Cedex, Ile-de-france, Франция, 94805
- Institut Gustave Roussy
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Limousin, Lorraine
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Limoges Cedex, Limousin, Lorraine, Франция, 87042
- Hôpital Dupuytren
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Provence Alpes COTE D'azur
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Marseille, Provence Alpes COTE D'azur, Франция, 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, Франция, 69495
- Centre Hospitalier Lyon Sud
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (ВЗРОСЛЫЙ, OLDER_ADULT)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: УХОД
- Распределение: РАНДОМИЗИРОВАННЫЙ
- Интервенционная модель: ПАРАЛЛЕЛЬ
- Маскировка: НИКТО
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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ЭКСПЕРИМЕНТАЛЬНАЯ: 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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ТАК-659 Таблетки
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ЭКСПЕРИМЕНТАЛЬНАЯ: 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).
|
ТАК-659 Таблетки
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Stage 2: ORR as Assessed by Independent Radiologic Review Committee (IRRC) Based on Modified 2007 International Working Group (IWG) Criteria
Временное ограничение: Up to 12 months
|
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.
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Up to 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Stage 2: CR Rate as Assessed by IRC Based on Modified 2007 IWG Criteria
Временное ограничение: Up to 12 months
|
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
Временное ограничение: Up to 12 months
|
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.
|
Up to 12 months
|
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Stage 2: CR Rate as Assessed by IRRC Based on 2014 IWG-Lugano Criteria
Временное ограничение: 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.
|
Up to 12 months
|
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Stage 2: Duration of Response (DOR)
Временное ограничение: Up to 12 months
|
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.
|
Up to 12 months
|
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Stage 2: Duration of CR
Временное ограничение: 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.
|
Up to 12 months
|
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Stage 2: ORR as Assessed by IRRC in Participants With Germinal Center B-cell (GCB) DLBCL
Временное ограничение: До 12 месяцев
|
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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До 12 месяцев
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Stage 2: ORR as Assessed by IRC in Participants With DLBCL Transformed From Indolent Non-Hodgkin's Lymphoma (NHL)
Временное ограничение: 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
|
|
Stage 2: Progression Free Survival (PFS) as Assessed by IRC
Временное ограничение: 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.
|
Up to 18 months
|
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Stage 2: Overall Survival (OS)
Временное ограничение: Up to 24 months
|
OS was defined as the time from start of study treatment to date of death due to any cause.
|
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
Временное ограничение: 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
|
|
Stage 2: ORR as Assessed by IRC at 3, 6, and 9 Cycles in Participants With DLBCL
Временное ограничение: 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.
|
At Cycles 3, 6 and 9 (Up to 12 months) (Each cycle of 28 days)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (ДЕЙСТВИТЕЛЬНЫЙ)
10 октября 2017 г.
Первичное завершение (ДЕЙСТВИТЕЛЬНЫЙ)
17 декабря 2019 г.
Завершение исследования (ДЕЙСТВИТЕЛЬНЫЙ)
17 декабря 2019 г.
Даты регистрации исследования
Первый отправленный
17 апреля 2017 г.
Впервые представлено, что соответствует критериям контроля качества
20 апреля 2017 г.
Первый опубликованный (ДЕЙСТВИТЕЛЬНЫЙ)
21 апреля 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (ДЕЙСТВИТЕЛЬНЫЙ)
8 февраля 2023 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 февраля 2023 г.
Последняя проверка
1 февраля 2023 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- C34004
- U1111-1187-6208 (ДРУГОЙ: WHO)
- 2016-003716-12 (EUDRACT_NUMBER)
- 17/YH/0181 (РЕГИСТРАЦИЯ: NRES)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Диффузная крупная В-клеточная лимфома
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Medical College of WisconsinUniversity of Wisconsin, Madison; AmgenРекрутингВ-клеточный острый лимфобластный лейкоз | B-клеточный острый лимфобластный лейкоз у детей | B-Cell ВСЕ, ДетствоСоединенные Штаты
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Galapagos NVАктивный, не рекрутирующийРецидивирующая/рефрактерная В-клеточная неходжкинская лимфома | Лимфомы неходжкин, amp;#39; s b-cellСоединенные Штаты, Бельгия, Нидерланды
Клинические исследования ТАК-659
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Calithera Biosciences, IncОтозванЛимфома, злокачественная | Продвинутые солидные новообразованияСоединенные Штаты
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Calithera Biosciences, IncПрекращеноЛимфома, неходжкинская | Лимфома, фолликулярная, маргинальная зонаКорея, Республика, Япония
-
Calithera Biosciences, IncПрекращеноОстрый миелогенный лейкозСоединенные Штаты, Канада
-
Calithera Biosciences, IncЗавершенныйПродвинутые солидные опухоли и злокачественные лимфомыСоединенные Штаты, Испания, Италия, Соединенное Королевство
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Calithera Biosciences, IncОтозванПродвинутые солидные новообразования | Lymphoma Neoplasms
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Calithera Biosciences, IncПрекращеноДиффузная крупноклеточная B-клеточная лимфома без GCB/ABC | С мутациями MyD88 и/или CD79B и без нихСоединенные Штаты
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TakedaЗавершенныйЗдоровые волонтерыСоединенные Штаты
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Neurocrine BiosciencesTakedaПрекращеноШизофрения, мозжечковая атаксияСоединенное Королевство
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Calithera Biosciences, IncNektar TherapeuticsОтозванЛимфома, неходжкинскаяСоединенные Штаты, Канада
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CHDI Foundation, Inc.ЗавершенныйБолезнь ХантингтонаШвеция, Дания, Нидерланды, Норвегия