Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654037
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Testing the Addition of an Anti-Cancer Drug Abemaciclib to the Usual Chemotherapy Treatment 5-Fluorouracil for Metastatic Refractory Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic Refractory CRC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 tests the safety side effects and best dose of abemaciclib in combination with 5-fluorouracil and how well it works in treating patients with colorectal cancer that has spread from where it first started primary site to other places in the body metastatic and that has not responded to treatment refractory Abemaciclib a type of cyclin-dependent kinase inhibitor blocks certain proteins which may help keep tumor cells from growing 5-fluorouracil a type of antimetabolite stops cells from making deoxyribonucleic acid DNA and may kill tumor cells Giving abemaciclib in combination with 5-fluorouracil may be safe tolerable andor effective in treating patients with metastatic and refractory colorectal cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and tolerability maximum tolerated dose MTD and recommended phase 2 dose RP2D of abemaciclib in combination with 5-fluorouracil 5-FU in patients with colorectal cancer CRC
SECONDARY OBJECTIVES
I To estimate the anti-tumor activity of abemaciclib in combination with 5-FU II To determine the pharmacodynamics PD of abemaciclib in combination with 5-FU death receptor 5 DR5 dynamics and apoptosis
III To identify molecular subpopulations particularly sensitized to abemaciclib and 5-FU
IV To determine the pharmacokinetics PK of abemaciclib and 5-FU
EXPLORATORY OBJECTIVES
I To explore exposure-response relationships for abemaciclib and 5-FU II To evaluate circulating tumor DNA ctDNA as a predictor for treatment response to therapy
OUTLINE This is a dose-escalation study of abemaciclib in combination with 5-FU followed by a dose-expansion study
Patients receive abemaciclib orally PO twice daily BID on days 1-28 and 5-FU intravenously IV over 46 hours on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection throughout the study and may additionally undergo a tissue biopsy before treatment and on cycle 1 day 16
After completion of study treatment patients are followed up every 3 months for 6 months
I To determine the safety and tolerability maximum tolerated dose MTD and recommended phase 2 dose RP2D of abemaciclib in combination with 5-fluorouracil 5-FU in patients with colorectal cancer CRC
SECONDARY OBJECTIVES
I To estimate the anti-tumor activity of abemaciclib in combination with 5-FU II To determine the pharmacodynamics PD of abemaciclib in combination with 5-FU death receptor 5 DR5 dynamics and apoptosis
III To identify molecular subpopulations particularly sensitized to abemaciclib and 5-FU
IV To determine the pharmacokinetics PK of abemaciclib and 5-FU
EXPLORATORY OBJECTIVES
I To explore exposure-response relationships for abemaciclib and 5-FU II To evaluate circulating tumor DNA ctDNA as a predictor for treatment response to therapy
OUTLINE This is a dose-escalation study of abemaciclib in combination with 5-FU followed by a dose-expansion study
Patients receive abemaciclib orally PO twice daily BID on days 1-28 and 5-FU intravenously IV over 46 hours on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection throughout the study and may additionally undergo a tissue biopsy before treatment and on cycle 1 day 16
After completion of study treatment patients are followed up every 3 months for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None