Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05109728
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2021-10-27
Brief Title:
A Dose Finding Study of 177LuLu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Dose Finding Study Assessing Safety and Activity of 177LuLu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Dose Finding Study of 177LuLu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Standard of Care and in Recurrent Glioblastoma as a Single Agent
Detailed Description:
The study for each participant consists of a Screening period a Treatment period and a 12-month Follow-up period
During the screening period of up to 6 weeks before starting GBM treatment each participant will be assessed for somatostatin receptor SSTR expression by 68GaGa-DOTA-TATE imaging PETscan
Eligible participants with newly diagnosed glioblastoma will be assigned to Group 1
Participants in Group 1 concomitant radiotherapy temozolomide and temozolomide maintenance will receive treatment with 177LuLu-DOTA-TATE every 4 weeks - 2 days up to 6 administrations Radiotherapy and temozolomide will be administered 7 to 10 days after the first administration of 177LuLu-DOTA-TATE Temozolomide will be administered orally at a dose of 75 mgm2day during the concomitant period concurrently with radiotherapy Radiotherapy will be delivered at a dose of 2 Gray Gyday 5 days per week followed by 2 days of rest for 6 consecutive weeks with a total dose of 60 Gy without interruption During the maintenance period there is an intra-patient dose escalation in temozolomide treatment The dosage of temozolomide is 150 mgm2 in Cycle 1 of maintenance period and then to 200 mgm2 in Cycle 2 and beyond in the maintenance period if 150 mgm2 temozolomide treatment is well tolerated in Cycle 1
Eligible participants with recurrent glioblastoma will be assigned to Group 3 and will receive 177LuLu-DOTA-TATE as single agent treatment every 3 weeks - 2 days
An infusion of sterile 25 Lysine - Arginine amino acid AA solution will be co-administered with each 177LuLu-DOTA-TATE dose for renal protection
During the screening period of up to 6 weeks before starting GBM treatment each participant will be assessed for somatostatin receptor SSTR expression by 68GaGa-DOTA-TATE imaging PETscan
Eligible participants with newly diagnosed glioblastoma will be assigned to Group 1
Participants in Group 1 concomitant radiotherapy temozolomide and temozolomide maintenance will receive treatment with 177LuLu-DOTA-TATE every 4 weeks - 2 days up to 6 administrations Radiotherapy and temozolomide will be administered 7 to 10 days after the first administration of 177LuLu-DOTA-TATE Temozolomide will be administered orally at a dose of 75 mgm2day during the concomitant period concurrently with radiotherapy Radiotherapy will be delivered at a dose of 2 Gray Gyday 5 days per week followed by 2 days of rest for 6 consecutive weeks with a total dose of 60 Gy without interruption During the maintenance period there is an intra-patient dose escalation in temozolomide treatment The dosage of temozolomide is 150 mgm2 in Cycle 1 of maintenance period and then to 200 mgm2 in Cycle 2 and beyond in the maintenance period if 150 mgm2 temozolomide treatment is well tolerated in Cycle 1
Eligible participants with recurrent glioblastoma will be assigned to Group 3 and will receive 177LuLu-DOTA-TATE as single agent treatment every 3 weeks - 2 days
An infusion of sterile 25 Lysine - Arginine amino acid AA solution will be co-administered with each 177LuLu-DOTA-TATE dose for renal protection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003672-14 | EUDRACT_NUMBER | None | None |