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Набира участници Фаза 3 2024-519818-31-01

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

Фаза 3 – широко изпитване преди одобрение
Заболявания: Endometrial Cancer Advanced Recurrent Metastatic or Primary Unresectable Endometrial Cancer

Спонсор: Genmab A/S

Налично на: БГ
Обобщение
Trial status: Authorised Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC, PFS, per RECIST v1.1, as determined by investigator assessment, ORR, per RECIST v1.1, as Determined by investigator assessment, Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment, DOR, per RECIST v1.1, as Determined by BICR, Number of Participants with Treatment-emergent Adverse Events (TEAEs), Change from Baseline in Global Health Status/Quality of Life (GHS/Qol), Time to Deterioration (TTD) in GHS/Qol 1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years], 2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]
Описание
Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC, PFS, per RECIST v1.1, as determined by investigator assessment, ORR, per RECIST v1.1, as Determined by investigator assessment, Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment, DOR, per RECIST v1.1, as Determined by BICR, Number of Participants with Treatment-emergent Adverse Events (TEAEs), Change from Baseline in Global Health Status/Quality of Life (GHS/Qol), Time to Deterioration (TTD) in GHS/Qol
Кой може да участва
Age group: 65+ years, 18-64 years Gender: Female Target enrollment: 226 participants
Интервенции
DOXORUBICIN
Drug
Rinatabart Sesutecan
Drug
PACLITAXEL
Drug
Места на провеждане 11
Белгия (1)
Дания (1)
Финландия (1)
Франция (1)
Германия (1)
Гърция (1)
Италия (1)
Lithuania (1)
Норвегия (1)
Полша (1)
Испания (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.03.2026
Регистрационен номер
2024-519818-31-01
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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