A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)
10 января 2020 г. обновлено: Eli Lilly and Company
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
132
Фаза
- Фаза 2
Расширенный доступ
Доступный вне клинических испытаний.
См. запись расширенного доступа.
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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Brussel, Бельгия, 1000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charleroi, Бельгия, 6000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven, Бельгия, 3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Liège, Бельгия, 4000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Испания, 08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Испания, 28007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia, Испания, 46015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Sedona, Arizona, Соединенные Штаты, 86336
- Northern Arizona Hematology & Oncology Associates
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Tucson, Arizona, Соединенные Штаты, 85715
- Arizona Clinical Research Center
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Tucson, Arizona, Соединенные Штаты, 85704
- HOPE Hematology Oncology Physicians and Extenders
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California
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San Francisco, California, Соединенные Штаты, 94115
- Univ of California San Francisco
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Santa Barbara, California, Соединенные Штаты, 93105
- Sansum Medical Research Foundation
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Colorado
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Denver, Colorado, Соединенные Штаты, 80220
- Rocky Mountain Cancer Center
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20010
- Washington Hospital Center
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Florida
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Fort Myers, Florida, Соединенные Штаты, 33916
- Florida Cancer Specialists
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Miami, Florida, Соединенные Штаты, 33176
- Advanced Medical Specialties
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Saint Petersburg, Florida, Соединенные Штаты, 33705
- Florida Cancer Specialists
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Maryland
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Columbia, Maryland, Соединенные Штаты, 21044
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55404
- Minnesota Oncology/Hematology PA
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New York
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New York, New York, Соединенные Штаты, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45242
- Oncology Hematology Care Inc
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Research Institute SCRI
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Texas
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Austin, Texas, Соединенные Штаты, 78731
- Texas Oncology Cancer Center
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Bedford, Texas, Соединенные Штаты, 76022
- Texas Oncology - Bedford
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Dallas, Texas, Соединенные Штаты, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Соединенные Штаты, 75231
- Presbyterian Hospital Dallas
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Fort Worth, Texas, Соединенные Штаты, 76104
- The Center for Cancer and Blood Disorders
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Houston, Texas, Соединенные Штаты, 77024
- Texas Oncology-Memorial City
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Plano, Texas, Соединенные Штаты, 75093
- Texas Oncology-Plano West
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Sherman, Texas, Соединенные Штаты, 75090-0504
- Texas Oncology-Sherman
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The Woodlands, Texas, Соединенные Штаты, 77380
- US Oncology
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Tyler, Texas, Соединенные Штаты, 75702
- Tyler Cancer Center
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Washington
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Vancouver, Washington, Соединенные Штаты, 98684
- Northwest Cancer Specialists PC
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Dijon, Франция, 21034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris, Франция, 75248
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
Inclusion Criteria.
- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
Prior treatment with at least 2 chemotherapy regimens:
- At least 1 of these regimens must have been administered in the metastatic setting.
- At least 1 of these regimens must have contained a taxane.
- No more than 2 prior chemotherapy regimens in the metastatic setting.
- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
- Have discontinued all previous therapies for cancer.
- Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion Criteria:
- Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- Have had major surgery within 14 days of the initial dose of study drug.
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
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: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle).
Participants may continue to receive treatment until discontinuation criteria are met.
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Вводится перорально
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Временное ограничение: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Overall Survival (OS)
Временное ограничение: From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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OS defined as the time from first dose date to the date of death due to any cause.
For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
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From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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Duration of Response (DOR)
Временное ограничение: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier.
CR and PR were defined using the RECIST v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
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From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Progression Free Survival (PFS)
Временное ограничение: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant.
If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
Временное ограничение: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
Временное ограничение: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months.
CR, PR, or SD were defined using RECIST, v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
Временное ограничение: Cycle 6 Day 1
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A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
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Cycle 6 Day 1
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Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
Временное ограничение: Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
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Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
Временное ограничение: Cycle 6 Day 1
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EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties.
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
For functional domains and global health status, higher scores represent a better level of functioning.
For symptoms scales, higher scores represented a greater degree of symptoms.
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Cycle 6 Day 1
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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 июня 2014 г.
Первичное завершение (Действительный)
30 апреля 2016 г.
Завершение исследования (Действительный)
22 октября 2018 г.
Даты регистрации исследования
Первый отправленный
31 марта 2014 г.
Впервые представлено, что соответствует критериям контроля качества
31 марта 2014 г.
Первый опубликованный (Оценивать)
3 апреля 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 января 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 января 2020 г.
Последняя проверка
1 января 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 15419
- I3Y-MC-JPBN (Другой идентификатор: Eli Lilly and Company)
- 2013-005548-27 (Другой идентификатор: EudraCT Number)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Сроки обмена IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
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 Абемациклиб
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Multiple Myeloma Research ConsortiumEli Lilly and Company; GlaxoSmithKline; AbbVie; Takeda; Genentech, Inc.; Celgene Corporation и другие соавторыРекрутингРецидивирующая рефрактерная множественная миеломаСоединенные Штаты