INTRATUMORAL DNX-2401 ADMINISTRATION FOR RECURRENT AND REFRACTORY HIGH GRADE BRAIN TUMORS IN PEDIATRIC AND YOUNG ADULT PATIENTS
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
High grade malignant brain neoplasm
Спонсор: Clinica Universidad De Navarra
Налично на:
БГ
Обобщение
Trial status: Authorised
Number of AEs and SAEs per NCI-CTCAE criteria in first 12 weeks after DNX-2401 administration., Time to response., Duration of response., PFS, OS: 6- and 12- month PFS and OS rates., LPS/KPS and QoL (PedsQL™ Generic Score Scale) parameters compared to baseline.
Overall response rate (ORR), defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD for at least 12 weeks) as best response according to RAPNO criteria.
Описание
Number of AEs and SAEs per NCI-CTCAE criteria in first 12 weeks after DNX-2401 administration., Time to response., Duration of response., PFS, OS: 6- and 12- month PFS and OS rates., LPS/KPS and QoL (PedsQL™ Generic Score Scale) parameters compared to baseline.
Кой може да участва
Age group: 18-64 years, 0-17 years
Gender: Female, Male
Target enrollment: 39 participants