Spots Global Cancer Trial Database for A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Official Title: A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Study ID: NCT05765812
Study Description
Brief Summary: The primary purpose of Phase 1 (dose escalation) of this study is to identify the recommended Phase 2 dose (RP2D) of Debio 0123 in combination with temozolomide (TMZ) (Arm A) and in combination with TMZ and radiotherapy (RT) (Arm B) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). The primary purpose of Phase 2 of this study is to assess the efficacy of Debio 0123 at the RP2D in combination with TMZ, compared to standard of care (SOC) in adult participants with GBM.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Clinica Universidad de Navarra (CUN), Madrid, , Spain
South Texas Accelerated Research Therapeutics (START), Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Clinica Universidad de Navarra (CUN), Pamplona, , Spain
Universitaetsspital Zuerich, Zuerich, , Switzerland
Contact Details
Name: Study Director
Affiliation: Debiopharm International SA
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
