DZB-CS-202

Статус набора: Набор

---

Вся информация берётся из открытых источников

Номер РКИ:

337

Дата создания:

17.07.2020 0:00:00

Наименование ЛП:

Деразантиниб (BAL087, ARQ 087)

Организация, проводящая КИ:

Базилеа Фармасьютика Интернэшнл Лтд.

Страна разраб-ка:

Швейцария

Организация, привлеченная разработчиком ЛП:

АЙКЬЮВИА РДС ГезмбХ, 125167, г. Москва, Ленинградский проспект 37А, корп.14, ~

Начало (дата):

01.08.2020 0:00:00

Окончание (дата):

31.12.2028 0:00:00

№ протокола:

DZB-CS-202

Протокол:

№DZB-CS-202"" №DZB-CS-202"" № DZB-CS-202 "Исследование фазы 1b/2 с целью изучения применения деразантиниба в качестве монотерапии и комбинированной терапии в сочетании с паклитакселом, рамуцирумабом или атезолизумабом у пациентов с HER2-негативной аденокарциномой желудка с генетическими аберрациями в гене FGFR (FIDES-03)"""""

Фаза КИ:

I-II

Вид КИ:

ММКИ

Колич. мед. орг-й:

9

Колич. пациентов:

350

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: histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach male or female aged в ≥ 18 years negative her2 status obtained from the most recent available tissue sample inoperable recurrent, locally advanced adenocarcinoma or progressing stage iv adenocarcinoma of the gastro-esophageal junction or stomach, and disease progression after either standard first- or second-line treatment (substudy 1), or after standard first-line treatment (substudies 2 and 3) positive test for eligible fgfr aberrations (fgfr2 fusions / rearrangements / amplifications; fgfr1, fgfr2, or fgfr3 mutations / short variants) measurable disease as defined by the investigator using recist 1.1 criteria ecog ps of 0 or 1 men and women of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 150 days after the last dose of either investigational drug key

Критерии исключения:

exclusion criteria: prior anticancer or investigational drug treatment within an interval shorter than the following, as applicable: one chemotherapy or biological (e.g., antibody) cycle interval five half-lives of any small molecule investigational or licensed medicinal product two weeks, for any investigational medicinal product with an unknown half-life four weeks of curative radiotherapy seven days of palliative radiotherapy prior treatment with fgfr inhibitors (all substudies), and prior treatment with taxanes within 6 months prior to randomization and/or anti-vegf(r) therapeutic antibody or pathway-targeting agents (substudies 2 and 3), and prior treatment with anti-programmed cell death receptor-1 (pd-1) or anti-programmed death ligand-1 (pd-l1) therapeutic antibody or pathway-targeting agents (substudy 3) concurrent evidence of clinically significant corneal or retinal disorder history of clinically significant cardiac disorders and/or a qt interval corrected by fridericia's formula (qtcf) > 450 ms for males or > 460 ms for females known cns metastases concurrent uncontrolled or active infection with human immunodeficiency virus (hiv; known hiv 1/2 antibodies positive); active or chronic hepatitis b without current antiviral therapy and an hbv dna в ≥ 100 iu/ml virus (hbv); active hepatitis c virus (hcv) co-infection; active tuberculosis (for substudies 2 and 3) child-pugh b or c liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal syndrome, or clinically-meaningful ascites related to cirrhosis (for substudies 2 and 3) administration of a live, attenuated vaccine within 30 days prior to randomization (for substudy 3) treatment with systemic corticosteroids (except for steroidal replacement therapy) or other systemic immunosuppressive medications within 2 weeks prior to first dose of study drug or anticipated requirement for systemic immunosuppressive medications during the study (for substudy 3)