The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer (GenCInibs-Suni)
28 января 2020 г. обновлено: Centre Hospitalier Universitaire de Nīmes
The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants
The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml (effective concentration according to the current literature).
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
The secondary objectives of this study are:
To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with
- the [Suni]REq,
- the advent of toxicity,
- the tumor response.
To describe the variation in the [Suni]REq and the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq) at:
- the interindividual level,
- overtime, between chemotherapy cycles.
To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) to the [Suni]REq at:
- the interindividual level,
- overtime, between chemotherapy cycles.
To explore potential correlations between the [Suni]REq and
- toxicity,
- tumor response.
To explore potential correlations between the [ActEnt]REq and
- toxicity,
- tumor response.
To explore potential correlations between the ratio [Metab]REq / [Suni]REq and
- toxicity,
- tumor response.
Тип исследования
Наблюдательный
Регистрация (Действительный)
43
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Montpellier cedex 5, Франция, 34295
- CHRU de Montpellier - Hôpital Saint-Eloi
-
Nîmes Cedex 09, Франция, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
Nîmes Cedex 9, Франция, 30029
- Institut de Cancérologie du Gard (ICG)
-
-
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
Метод выборки
Вероятностная выборка
Исследуемая популяция
The study population consisted of patients with renal cell carcinoma treated with sunitinib (Sutent).
Описание
Inclusion Criteria:
- The patient was correctly informed concerning the implementation of the study, its objectives, constraints and patient rights
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has kidney cancer and should begin treatment with sunitinib (Sutent) at the time of inclusion
Exclusion Criteria:
- The patient started treatment with sunitinib (Sutent) before inclusion
- The patient is participating in another interventional study
- The patient has participated in another interventional study within the last month
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contraindication (or an incompatible drug combination) for a treatment used in this study
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
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
The study population
Patients with kidney cancer and will be starting treatment via sunitinib at the study start will be included. Intervention: Blood drawn for genotyping Intervention: Blood drawn for pharmacokinetic measures |
Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
Blood will be drawn for pharmacokinetic measures between CmD15 and CmD28 of each sunitinib cycle.* *Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal). Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order. Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Genotype: genetic polymorphisms of enzymes of phase I, phase II (conjugation), carriers of Phases 0 and III, the nuclear receptors PXR and CAR, pharmacological targets of sunitinib (tyrosine kinase receptors).
Временное ограничение: Baseline (day 0)
|
Predefined list of genes: ABCB1 ABCC2 ABCG2 CYP1A1 CYP1A2 CYP2A6 CYP2B6 CYP2C19 CYP2C8 CYP2C9 CYP2D6 CYP2E1 CYP3A4 CYP3A5 NR1I2 NR1I3 SLC15A2 SLC22A1 SLC22A2 SLC22A6 SLCO1B1 SLCO1B3 SULT1A1 UGT1A1 UGT2B15 UGT2B17 UGT2B7 VEGFR1,2,3 PDGFR-α et β KIT |
Baseline (day 0)
|
|
[Suni]REq per cure
Временное ограничение: Between CmD15* and CmD28* for 18 months
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between CmD15* and CmD28* for 18 months
|
|
The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure
Временное ограничение: 18 months
|
18 months
|
|
|
Tumor response per cure
Временное ограничение: 18 months
|
18 months
|
|
|
Toxicity (yes/no) for each type of toxic event per cure
Временное ограничение: Between CmD15* and CmD28* for 18 months
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between CmD15* and CmD28* for 18 months
|
|
[Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
|
the average [Suni]REq over all cures
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the average [Suni]REq for cure 1 to cure m
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq
Временное ограничение: Between CmD15* and CmD28* for 18 months
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between CmD15* and CmD28* for 18 months
|
|
[Metab]REq / [Suni]REq
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
|
[Metab]REq / [Suni]REq averaged per initial dosing
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
|
Mean [Metab]REq / [Suni]REq for all cures
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)
Временное ограничение: 18 months
|
18 months
|
|
|
[ActEnt]REq
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
|
[ActEnt]REq averaged per initial dosing
Временное ограничение: Between C1D15* and C1D28*
|
*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal).
Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order.
Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
|
Between C1D15* and C1D28*
|
|
Mean [ActEnt]REq for all cures
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the average [ActEnt]REq for cure 1 to cure m
Временное ограничение: 18 months
|
18 months
|
|
|
For each cure, the % of patients whose dosings were modified since the beginning of the study
Временное ограничение: 18 months
|
18 months
|
|
|
Presence/absence of side effects noted in the summary of product characteristics for sunitinib
Временное ограничение: 18 months
|
18 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Litaty Mbatchi, PharmD, Centre Hospitalier Universitaire de Nîmes
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)
29 декабря 2015 г.
Первичное завершение (Действительный)
21 мая 2019 г.
Завершение исследования (Действительный)
21 мая 2019 г.
Даты регистрации исследования
Первый отправленный
26 марта 2015 г.
Впервые представлено, что соответствует критериям контроля качества
30 марта 2015 г.
Первый опубликованный (Оценивать)
31 марта 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
29 января 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 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
- LOCAL/2014/LM-01bis
- 2014-005534-55 (Номер EudraCT)
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. .