Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2020-11-04
Brief Title:
Testing the Addition of an Anti-cancer Drug Elimusertib BAY 1895344 ATR Inhibitor to the Chemotherapy Treatment Gemcitabine for Advanced Pancreatic and Ovarian Cancer and Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 1 Trial of Gemcitabine Combined With the Elimusertib BAY 1895344 ATR Inhibitor With Expansion Cohorts in Advanced Pancreatic and Ovarian Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 identifies the best dose possible benefits andor side effects of gemcitabine in combination with elimusertib BAY 1895344 in treating patients with pancreatic ovarian and other solid tumors that have spread to other places in the body advanced Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the safety and tolerability of gemcitabine in combination with elimusertib BAY 1895344 as assessed by Common Terminology Criteria for Adverse Events CTCAE 50 Dose Escalation and Expansion Cohort II Determine the maximum tolerated dose MTD of gemcitabine in combination with elimusertib BAY 1895344 Dose Escalation Cohort
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II Analyze the pharmacokinetic PK profile of the gemcitabine and elimusertib BAY 1895344 combination
III Assessing whether immunohistochemical markers of deoxyribonucleic acid DNA damage gamma-H2AX and phosphorylated pNBS1 increase in on-treatment biopsies compared to the levels seen in pre-treatment biopsies
EXPLORATORY OBJECTIVES
I Explore biomarkers that predict response to this combination II Evaluate mechanisms of acquired resistance to this combination
OUTLINE This is a dose-escalation study of gemcitabine followed by a dose expansion study
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 and 8 and elimusertib orally PO once daily QD or twice daily BID on days 2-3 and 9-10 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial and collection of blood samples during screening and on days 1 2 and 9-10 of cycle 1 Patients in the dose-expansion portion of the trial also undergo biopsies during screening and on day 9 of cycle 1
After completion of study treatment patients are followed up for 30 days
I Evaluate the safety and tolerability of gemcitabine in combination with elimusertib BAY 1895344 as assessed by Common Terminology Criteria for Adverse Events CTCAE 50 Dose Escalation and Expansion Cohort II Determine the maximum tolerated dose MTD of gemcitabine in combination with elimusertib BAY 1895344 Dose Escalation Cohort
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II Analyze the pharmacokinetic PK profile of the gemcitabine and elimusertib BAY 1895344 combination
III Assessing whether immunohistochemical markers of deoxyribonucleic acid DNA damage gamma-H2AX and phosphorylated pNBS1 increase in on-treatment biopsies compared to the levels seen in pre-treatment biopsies
EXPLORATORY OBJECTIVES
I Explore biomarkers that predict response to this combination II Evaluate mechanisms of acquired resistance to this combination
OUTLINE This is a dose-escalation study of gemcitabine followed by a dose expansion study
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 and 8 and elimusertib orally PO once daily QD or twice daily BID on days 2-3 and 9-10 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity All patients also undergo medical imaging scans after cycle 2 and then every 9 weeks throughout the trial and collection of blood samples during screening and on days 1 2 and 9-10 of cycle 1 Patients in the dose-expansion portion of the trial also undergo biopsies during screening and on day 9 of cycle 1
After completion of study treatment patients are followed up for 30 days
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-2020-08370 | REGISTRY | None | None |
| 10403 | OTHER | None | None |
| 10403 | OTHER | None | None |
| UM1CA186709 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186709 |