Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691491
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-01-18
Brief Title:
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 12 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774
Status:
RECRUITING
Status Verified Date:
2024-05
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 III trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started primary site to other places in the body metastatic and may have spread to nearby tissue lymph nodes or distant parts of the body advanced Temozolomide is in a class of medications called alkylating agents It works by damaging the cells deoxyribonucleic acid DNA and may kill tumor cells and slow down or stop tumor growth M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine the maximum tolerated dose of the combination of temozolomide TMZ and tuvusertib M1774
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II To determine the overall response rate III To estimate progression free survival IV To estimate overall survival V To determine the recommended phase 2 dose of the combination of TMZ and M1774
EXPLORATORY OBJECTIVES
I Correlate MGMT promoter hypermethylation MGMT expression and tumor-infiltrating lymphocytes TILs with efficacy endpoints of response rate progression free survival and overall survival
II Assess pre and post treatment tumor biopsies for changes in tumor mutational burden tumor associated neo-antigens and microsatellite status by whole exome sequencing
III Measure changes in peripheral blood mononuclear cell populations with treatment
IV Assess liquid biopsies by circulating tumor ctDNA for changes in tumor mutational burden and microsatellite status by whole exome sequencing
OUTLINE This is a phase I dose-escalation study of temozolomide and tuvusertib followed by a phase II study
Patients receive tuvusertib orally PO once daily QD on days 1-7 and temozolomide PO QD on days 1-5 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan and magnetic resonance imaging MRI as well as collection of blood samples throughout the trial Patients also undergo a biopsy at baseline and may undergo one on study andor time of progression
After completion of study treatment patients are followed up at 4 weeks and then every 3 months for up to 2 years
I To determine the maximum tolerated dose of the combination of temozolomide TMZ and tuvusertib M1774
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II To determine the overall response rate III To estimate progression free survival IV To estimate overall survival V To determine the recommended phase 2 dose of the combination of TMZ and M1774
EXPLORATORY OBJECTIVES
I Correlate MGMT promoter hypermethylation MGMT expression and tumor-infiltrating lymphocytes TILs with efficacy endpoints of response rate progression free survival and overall survival
II Assess pre and post treatment tumor biopsies for changes in tumor mutational burden tumor associated neo-antigens and microsatellite status by whole exome sequencing
III Measure changes in peripheral blood mononuclear cell populations with treatment
IV Assess liquid biopsies by circulating tumor ctDNA for changes in tumor mutational burden and microsatellite status by whole exome sequencing
OUTLINE This is a phase I dose-escalation study of temozolomide and tuvusertib followed by a phase II study
Patients receive tuvusertib orally PO once daily QD on days 1-7 and temozolomide PO QD on days 1-5 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan and magnetic resonance imaging MRI as well as collection of blood samples throughout the trial Patients also undergo a biopsy at baseline and may undergo one on study andor time of progression
After completion of study treatment patients are followed up at 4 weeks and then every 3 months for up to 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-10211 | REGISTRY | None | None |
| 10572 | OTHER | None | None |
| 10572 | OTHER | None | None |
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |