Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535401
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-09-01
Brief Title:
Testing the Addition of an Anticancer Drug BAY 1895344 to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIb Trial of ATR Inhibitor BAY 1895344 in Combination With FOLFIRI in GI Malignancies With a Focus on Metastatic Colorectal and GastricGastroesophageal Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This phase I trial investigates the best dose possible benefits andor side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced or has spread from where it first started primary site to other places in the body metastatic BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Chemotherapy drugs such as irinotecan fluorouracil and leucovorin called FOLFIRI in short 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 BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach andor intestinal cancer
Detailed Description:
PRIMARY OBJECTIVE
I Determine the safety and maximum tolerated dose MTD of elimusertib BAY 1895344 with leucovorin calcium fluorouracil and irinotecan hydrochloride FOLFIRI
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity by overall response rate ORR progression-free survival PFS and overall survival OS
II Determine the response and clinical benefit rate complete response partial response stable disease of BAY 1895344 with FOLFIRI in colorectal and gastricgastroesophageal cancers
III Evaluate tumor and peripheral blood mononuclear cell PBMC deoxyribonucleic acid DNA damage signaling in the context of the chemotherapy backbone alone and when combined with BAY 1895344
IV Evaluate the pharmacokinetics PK profile of fluorouracil 5-FU and irinotecan
V Evaluate the PK profile of BAY 1895344 VI Evaluate the relationship between ATM status by immunohistochemistry IHC and clinical efficacy of the BAY 1895344FOLFIRI combination
EXPLORATORY OBJECTIVES
I Evaluate the exposure-response relationship between drug exposures and toxicity and response and UGT1A1 genotype
II Evaluate the relationship between tumor mutations and clinical efficacy of the BAY 1895344FOLFIRI combination
OUTLINE This is a dose-escalation study of elimusertib irinotecan and fluorouracil with fixed-dose leucovorin followed by a dose-expansion study
Patients receive elimusertib orally PO once daily QD on days 2 3 16 and 17 and irinotecan hydrochloride intravenously IV over 90 minutes fluorouracil IV over 46 hours and leucovorin calcium IV on days 1 and 15 Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study
After completion of study treatment patients are followed up for 30 days and then every 3 months for up to 1 year or until their disease gets worse or they begin a new treatment for their cancer
I Determine the safety and maximum tolerated dose MTD of elimusertib BAY 1895344 with leucovorin calcium fluorouracil and irinotecan hydrochloride FOLFIRI
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity by overall response rate ORR progression-free survival PFS and overall survival OS
II Determine the response and clinical benefit rate complete response partial response stable disease of BAY 1895344 with FOLFIRI in colorectal and gastricgastroesophageal cancers
III Evaluate tumor and peripheral blood mononuclear cell PBMC deoxyribonucleic acid DNA damage signaling in the context of the chemotherapy backbone alone and when combined with BAY 1895344
IV Evaluate the pharmacokinetics PK profile of fluorouracil 5-FU and irinotecan
V Evaluate the PK profile of BAY 1895344 VI Evaluate the relationship between ATM status by immunohistochemistry IHC and clinical efficacy of the BAY 1895344FOLFIRI combination
EXPLORATORY OBJECTIVES
I Evaluate the exposure-response relationship between drug exposures and toxicity and response and UGT1A1 genotype
II Evaluate the relationship between tumor mutations and clinical efficacy of the BAY 1895344FOLFIRI combination
OUTLINE This is a dose-escalation study of elimusertib irinotecan and fluorouracil with fixed-dose leucovorin followed by a dose-expansion study
Patients receive elimusertib orally PO once daily QD on days 2 3 16 and 17 and irinotecan hydrochloride intravenously IV over 90 minutes fluorouracil IV over 46 hours and leucovorin calcium IV on days 1 and 15 Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study
After completion of study treatment patients are followed up for 30 days and then every 3 months for up to 1 year or until their disease gets worse or they begin a new treatment for their cancer
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-2020-06482 | REGISTRY | None | None |
| 21-060 | None | None | None |
| 10406 | OTHER | None | None |
| 10406 | OTHER | None | None |
| UM1CA186690 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186690 |