Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04555577
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2020-08-10
Brief Title:
Peposertib and Radiation Therapy Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Trial of DNA-PK Inhibitor M3814 in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial investigates the side effects and best dose of Peposertib and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors Peposertib may further stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Chemotherapy drugs such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving Peposertib with radiation therapy may work better than radiation therapy alone in treating patients with glioblastoma or gliosarcoma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of Peposertib M3814 in combination with standard of care radiation dose 60 Gy 2 Gyfraction over 6 weeks in patients with newly diagnosed MGMT unmethylated glioblastoma GBM Stage I II To determine the ability of M3814 to cross the blood brain barrier and to evaluate their pharmacodynamic properties in resected tissue Stage II
SECONDARY AND EXPLORATORY OBJECTIVES
I To evaluate the dose limiting toxicities DLT Stage I Secondary Objective II To determine the overall response rate ORR median progression free survival mPFS and median overall survival mOS of M3814 in combination with radiation Stage I Secondary Objective II To determine the overall response rate ORR median progression free survival mPFS and median overall survival mOS of M3814 in combination with radiation Stage II Exploratory Objective
CORRELATIVE OBJECTIVES
I To evaluate pharmacodynamic properties of M3814 II To assess the alterations in tumor immune microenvironment as a result of deoxyribonucleic acid DNA-dependent protein kinase DNA-PK inhibition
OUTLINE This is a dose-escalation study of Peposertib Patients are assigned to 1 of 2 stages
STAGE I CONCURRENT Patients undergo standard of care radiation therapy daily Monday-Friday for 30 fractions Patients also receive Peposertib orally PO on each day of radiation therapy and given 1-2 hours before each treatment fraction Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity
STAGE I ADJUVANT Patients receive temozolomide PO once daily QD on days 1-5 Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
STAGE II CONCURRENT Patients receive Peposertib and undergo standard of care radiation therapy as in Stage I Within 1-14 days after the completion of radiation therapy patients undergo surgical resection
STAGE II ADJUVANT Patients receive temozolomide as in Stage I
After completion of study treatment patients are followed up every 3 months
I To determine the maximum tolerated dose MTD of Peposertib M3814 in combination with standard of care radiation dose 60 Gy 2 Gyfraction over 6 weeks in patients with newly diagnosed MGMT unmethylated glioblastoma GBM Stage I II To determine the ability of M3814 to cross the blood brain barrier and to evaluate their pharmacodynamic properties in resected tissue Stage II
SECONDARY AND EXPLORATORY OBJECTIVES
I To evaluate the dose limiting toxicities DLT Stage I Secondary Objective II To determine the overall response rate ORR median progression free survival mPFS and median overall survival mOS of M3814 in combination with radiation Stage I Secondary Objective II To determine the overall response rate ORR median progression free survival mPFS and median overall survival mOS of M3814 in combination with radiation Stage II Exploratory Objective
CORRELATIVE OBJECTIVES
I To evaluate pharmacodynamic properties of M3814 II To assess the alterations in tumor immune microenvironment as a result of deoxyribonucleic acid DNA-dependent protein kinase DNA-PK inhibition
OUTLINE This is a dose-escalation study of Peposertib Patients are assigned to 1 of 2 stages
STAGE I CONCURRENT Patients undergo standard of care radiation therapy daily Monday-Friday for 30 fractions Patients also receive Peposertib orally PO on each day of radiation therapy and given 1-2 hours before each treatment fraction Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity
STAGE I ADJUVANT Patients receive temozolomide PO once daily QD on days 1-5 Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
STAGE II CONCURRENT Patients receive Peposertib and undergo standard of care radiation therapy as in Stage I Within 1-14 days after the completion of radiation therapy patients undergo surgical resection
STAGE II ADJUVANT Patients receive temozolomide as in Stage I
After completion of study treatment patients are followed up every 3 months
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 |
|---|---|---|---|
| NCI-2020-04491 | REGISTRY | None | None |
| 2019-1035 | OTHER | M D Anderson Cancer Center | None |