WO41554

Статус набора: Набор

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Вся информация берётся из открытых источников

Номер РКИ:

41

Дата создания:

03.02.2020 0:00:00

Наименование ЛП:

RO7113755 (GDC-0077)

Организация, проводящая КИ:

Ф.Хоффманн-Ля Рош Лтд.

Страна разраб-ка:

Швейцария

Организация, привлеченная разработчиком ЛП:

Ф. Хоффманн-Ля Рош Лтд., Grenzacherstrasse 124, 4070 Basel, Switzerland, Швейцария

Начало (дата):

03.02.2020 0:00:00

Окончание (дата):

26.02.2026 0:00:00

№ протокола:

WO41554

Протокол:

№WO41554"" № WO41554 "Двойное слепое, рандомизированное, плацебо-контролируемое исследование III фазы по оценке эффективности и безопасности препарата GDC-0077 в комбинации с палбоциклибом и фулвестрантом в сравнении с плацебо в комбинации с палбоциклибом и фулвестрантом у пациентов с PIK3CA-мутацией, с позитивным по рецепторам гормонов и HER2-негативным местно-распространенным или метастатическим раком молочной железы"""

Фаза КИ:

III

Вид КИ:

ММКИ

Колич. мед. орг-й:

9

Колич. пациентов:

300

Области применения:

Онкология;

Состояние:

Проводится

Ссылки:

clinicaltrials.gov

grls.rosminzdrav.ru

Критерии включения:

На данный момент переводчик не встроен, для перевода критериев исследования воспользуйтесь переводчиком встроенным в браузер, или любым другим.
inclusion criteria confirmed diagnosis of hr+/her2- breast cancer metastatic or locally advanced disease not amenable to curative therapy progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen receiving lhrh agonist therapy for at least 2 weeks prior to day 1 of cycle 1 if pre/peri-menopausal confirmation of biomarker eligibility (detection of specified mutation(s) of pik3ca via specified test) consent to provide fresh or archival tumor tissue specimen measurable disease per response evaluation criteria in solid tumors, version 1.1; "bone-only" disease, even if considered measurable, is not eligible eastern cooperative oncology group performance status of 0 or 1 life expectancy of > 6 months adequate hematologic and organ function within 14 days prior to initiation of study treatment

Критерии исключения:

exclusion criteria metaplastic breast cancer any history of leptomeningeal disease or carcinomatous meningitis any prior systemic therapy for metastatic breast cancer prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months prior treatment with any pi3k, akt, or mtor inhibitor, or any agent whose mechanism of action is to inhibit the pi3k-akt-mtor pathway type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of type 1 diabetes known and untreated, or active cns metastases. patients with a history of treated cns metastases are eligible active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period symptomatic active lung disease, or requiring daily supplemental oxygen history of inflammatory bowel disease or active bowel inflammation anti-cancer therapy within 2 weeks before study entry investigational drug(s) within 4 weeks before randomization prior radiotherapy to > = 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation chronic corticosteroid therapy or immunosuppressants pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment major surgical procedure, or significant traumatic injury, within 28 days prior to day 1 of cycle 1