- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01253564
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
26 июня 2017 г. обновлено: Hoffmann-La Roche
An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases
This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases.
Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
Обзор исследования
Тип исследования
Интервенционный
Регистрация (Действительный)
24
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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Lausanne, Швейцария, 1011
- CHUV; Departement d'Oncologie
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Zürich, Швейцария, 8091
- Universitätsspital Zürich; Dermatologische Klinik
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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
Все
Описание
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
- Brain metastases for which surgical resection is not a treatment option
- Patients must have failed at least one previous treatment for brain metastases
- Requiring corticosteroids for symptom control
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
- Increasing corticosteroid dose during the 7 days prior to study entry
- Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- Concurrent administration of any anticancer therapies other than those administered in the study
- Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
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: Одинарная рука
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960 mg b.i.d. orally
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants With Adverse Events (AEs)
Временное ограничение: From baseline up to last dose (0.1 to 11.3 months) plus 28 days
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AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug.
Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs.
Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant.
Grade-1:discomfort but no disruption of normal daily activity.
Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death.
Any AE included participants with serious and non-serious AE.
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From baseline up to last dose (0.1 to 11.3 months) plus 28 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1).
CR was defined as disappearance of all target and non-target lesions and no new lesions.
PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
Best overall response was calculated separately for brain, other sites (extracranial) and whole body.
Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.
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Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Duration of Response by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)
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Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR.
CR and PR were assessed by investigator according to RECIST version 1.1.
CR was defined as disappearance of all target and non-target lesions and no new lesions.
PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
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Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)
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Time to Response by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first).
CR and PR were assessed by investigator according to RECIST version 1.1.
CR was defined as disappearance of all target and non-target lesions and no new lesions.
PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
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Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Duration of Stable Disease (SD) by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause.
SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
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Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Time to New Lesion by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions.
Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
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Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Percentage of Participants With Disease Progression or Death by Disease Site
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.
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Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Progression Free Survival (PFS)
Временное ограничение: Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first.
Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.
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Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)
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Percentage of Participants Who Died
Временное ограничение: Baseline up to end of the study and every 3 months during follow-up (up to 16 months)
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Percentage of participants who died due to any reason are reported.
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Baseline up to end of the study and every 3 months during follow-up (up to 16 months)
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Overall Survival (OS)
Временное ограничение: From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)
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OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.
Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival.
The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first.
OS was calculated by Kaplan-Meier estimates.
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From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)
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Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids
Временное ограничение: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
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An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.
Percentage of participants and 95% Clopper-Pearson CI are reported.
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Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
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Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic
Временное ограничение: Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
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An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.
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Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days
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Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain
Временное ограничение: Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)
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VAS is a measure of pain intensity.
The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale.
The beginning of the line represented no pain and the end of the line represented maximum pain.
Total score ranged from 0 - 100.
Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline.
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Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)
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Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status
Временное ограничение: Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)
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Physician's Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse).
An improvement was classed as a difference from baseline of at least -1 point.
Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.
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Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)
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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)
22 ноября 2010 г.
Первичное завершение (Действительный)
14 марта 2012 г.
Завершение исследования (Действительный)
14 марта 2012 г.
Даты регистрации исследования
Первый отправленный
2 декабря 2010 г.
Впервые представлено, что соответствует критериям контроля качества
2 декабря 2010 г.
Первый опубликованный (Оценивать)
3 декабря 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 июля 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 июня 2017 г.
Последняя проверка
1 июня 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Новообразования по гистологическому типу
- Новообразования
- Новообразования по локализации
- Нейроэктодермальные опухоли
- Новообразования, зародышевые клетки и эмбриональные
- Новообразования, нервная ткань
- Новообразования центральной нервной системы
- Новообразования нервной системы
- Нейроэндокринные опухоли
- Невусы и меланомы
- Новообразования головного мозга
- Меланома
Другие идентификационные номера исследования
- MO25653
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 RO5185426
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Hoffmann-La RocheЗавершенныйМеланомаСоединенные Штаты, Израиль, Италия, Испания, Бельгия, Соединенное Королевство, Австрия, Чехия, Франция, Нидерланды, Новая Зеландия, Российская Федерация, Австралия, Канада, Хорватия, Португалия, Германия, Украина, Швейцария, Ар... и более
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National Cancer Institute (NCI)Активный, не рекрутирующийСаркома мягких тканей | Остеосаркома | Саркома Юинга | Злокачественная глиома | Эпендимома | Рабдоидная опухоль | Продвинутое злокачественное солидное новообразование | Рефрактерное злокачественное солидное новообразование | Рабдомиосаркома | Рецидивирующее злокачественное солидное новообразование | Рецидивирующая... и другие заболеванияСоединенные Штаты, Пуэрто-Рико
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Hoffmann-La RocheЗавершенныйЗлокачественная меланомаКанада, Испания, Соединенное Королевство, Венгрия, Австралия, Австрия, Бельгия, Эквадор, Эстония, Финляндия, Ирландия, Италия, Корея, Республика, Мексика, Нидерланды, Португалия, Словения, Швеция, Турция, Бразилия, Индия, Германия, Босния... и более
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Yale UniversityGenentech, Inc.Завершенный
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Sidney Kimmel Comprehensive Cancer Center at Johns...Genentech, Inc.ОтозванМеланомаСоединенные Штаты
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ЗавершенныйМетастатическое злокачественное новообразование | Продвинутое злокачественное новообразование | Рецидивирующее злокачественное новообразование | Рефрактерное злокачественное новообразование | Мутация гена BRAFСоединенные Штаты
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Hoffmann-La RocheЗавершенныйЗлокачественная меланома, ракВенгрия
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National Cancer Institute (NCI)ПрекращеноНеуточненная солидная опухоль у взрослых, специфичная для протокола | Рецидивирующая меланома | Меланома IV стадии | Меланома IIIА стадии | Меланома стадии IIIB | Меланома стадии IIICСоединенные Штаты
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Mayo ClinicNational Cancer Institute (NCI)РекрутингКлиническая стадия III меланомы кожи AJCC v8 | Патологическая стадия IIIB меланомы кожи AJCC v8 | Патологическая стадия IIIC меланомы кожи AJCC v8 | Патологическая стадия IIID меланомы кожи AJCC v8 | Патологическая стадия III меланомы кожи AJCC v8 | Патологическая стадия IIIA меланомы кожи...Соединенные Штаты
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Genentech, Inc.Активный, не рекрутирующийСтадия IV колоректального рака AJCC v7 | Стадия IVA колоректального рака AJCC v7 | Колоректальный рак стадии IVB AJCC v7 | Метастатическое злокачественное солидное новообразование | Неоперабельное солидное новообразование | BRAF NP_004324.2:p.V600X | Аллель KRAS wtСоединенные Штаты