- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01855061
Biomarker Development for Response Prediction by DNA Mutational Analysis (CPCT-01)
Feasibility Study of Biomarker Development for Response Prediction by Large Scale DNA Mutational Analysis of Metastatic Lesions
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Utrecht, Нидерланды, 3584 CX
- University Medical Center Utrecht
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North Holland
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Amsterdam, North Holland, Нидерланды, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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South Holland
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Rotterdam, South Holland, Нидерланды, 3075 EA
- Erasmsus Medical Center - Daniël den Hoed clinic
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve.
- Patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan.
- Measurable metastatic lesion(s), according to RECIST 1.1 criteria.
Radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained:
- Patients with safely accessible metastases.
- Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
- Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID's, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted.
Adequate coagulation status on the day of biopsy as measured by:
- PTT < 1.5 x ULN
- APTT < 1.5 x ULN
- Platelet count 100 x 10*9 / L or higher
- PT-INR < 1.6
- HB > 6
- Biopsies should be performed at least four weeks after last bevacizumab administration.
- Patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
Exclusion Criteria:
Patients not meeting all of the above inclusion criteria.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Irinotecan
Patients will be subjected to a their metastatic solid tumor. Radiological response will be evaluated after each 2 cycles: 1. percentage change in radiological volume of the "index lesion" (radiological measurable lesion that underwent biopsy) after the first two cycles of irinotecan; 2. radiological response according to RECIST 1.1 after each 2 cycles. Patients are intended to receive irinotecan until progressive disease or unacceptable toxicity. Patients will be subjected to another biopsy of the index lesion at definitive discontinuation of irinotecan. Patients will also be subjected to blood draws for determining patient's genetic background variation. Side studies include:
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Histological biopsy of the "index lesion" (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease.
Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity.
Другие имена:
Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).
Другие имена:
Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).
Другие имена:
Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Exploration of the correlation between the mutational profile and the percentage change in volumetric measurement of the index lesion after the first two cycles of chemotherapy.
Временное ограничение: Change in radiological volume of the index lesion after the first 2 cycles of irinotecan. Radiological response (according to RECIST 1.1) after the first 2 cycles of irinotecan (i.e. after 2 x 3 weeks = 6 weeks)
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Change in radiological volume of the index lesion after the first 2 cycles of irinotecan. Radiological response (according to RECIST 1.1) after the first 2 cycles of irinotecan (i.e. after 2 x 3 weeks = 6 weeks)
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
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Exploration of the correlation between the mutational profile and radiological response according to RECIST-criteria after the first two cycles of chemotherapy.
Временное ограничение: Analysis 6 weeks after initiation of treatment
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Analysis 6 weeks after initiation of treatment
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Exploration of the correlation between the mutational profile and progression free survival and overall survival.
Временное ограничение: Overall survival approximately after 2 years of first cycle of irinotecan. Progression free survival approximately 3 months after first irinotecan
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Overall survival approximately after 2 years of first cycle of irinotecan. Progression free survival approximately 3 months after first irinotecan
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Exploration of the correlation between the mutational profile of the index lesion and patient's germline DNA background variation.
Временное ограничение: Analysis after progressive disease, on average after 3 months.
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Analysis after progressive disease, on average after 3 months.
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Differences in mutational profile of metastasis prior to and after exposure to treatment.
Временное ограничение: Analysis after progressive disease and subsequent post-treatment biopsy, on average after 3 months of treatment
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Analysis after progressive disease and subsequent post-treatment biopsy, on average after 3 months of treatment
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Determine reliable and valid strategies for statistical analysis for biomarker discovery
Временное ограничение: 2 years
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2 years
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Correlate response to pharmacokinetics of SN-38
Временное ограничение: After progressive disease and subsequent post-treatment biopsy, in general after 3 months of treatment
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After progressive disease and subsequent post-treatment biopsy, in general after 3 months of treatment
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Determine carboxylesterase activity in metastatic tumor material (pre- and posttreatment) and correlate intra-tumoral carboxylesterase activity to systemic SN-38 pharmacokinetics and to irinotecan response
Временное ограничение: After progressive disease and subsequent post-treatment biopsy, in general after 3 months of treatment
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After progressive disease and subsequent post-treatment biopsy, in general after 3 months of treatment
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Determine clinical applicability of the midazolam phenotyping probe
Временное ограничение: After first cycle of irinotecan, at three weeks
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After first cycle of irinotecan, at three weeks
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Number and nature of all (serious) adverse events of study related procedures
Временное ограничение: 14 days after baseline biopsy and 14 days after post-treatment biopsy (approximately after 3 months of treatment)
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14 days after baseline biopsy and 14 days after post-treatment biopsy (approximately after 3 months of treatment)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marlies Langenberg, MD/PhD, UMC Utrecht
- Главный следователь: Neeltje Steeghs, MD/PhD, Netherlands Cancer Institute - Antoni van Leeuwenhoek hospital, Amsterdam
- Главный следователь: Ron Mathijssen, MD/PhD, Erasmus Medical Center - Daniël den Hoed clinic, Rotterdam
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Новообразования
- Неопластические процессы
- Метастаз новообразования
- Физиологические эффекты лекарств
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Депрессанты центральной нервной системы
- Анестетики внутривенные
- Анестетики, Общие
- Анестетики
- Успокоительные агенты
- Психотропные препараты
- Снотворные и седативные средства
- Адъюванты, Анестезия
- Противотревожные агенты
- Модуляторы ГАМК
- Агенты ГАМК
- Мидазолам
Другие идентификационные номера исследования
- NL35198.041.11
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 Biopsy
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NeoDynamics ABРекрутингРак молочной железыСоединенное Королевство