Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03714958
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2018-10-17
Brief Title:
Trametinib HDM201 in CRC Patients With RASRAF Mutant and TP53 Wild-type AdvancedMetastatic Colorectal Cancer Mutant and TP53 Wild-type
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Single-center Phase 1 Dose Escalation Study of Trametinib Combined With HDM201 in Patients With RASRAF Mutant and TP53 Wild-type AdvancedMetastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-09
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:
TRAHD
Brief Summary:
Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RASBRAF-mutant and TP53 wild-type CRC models In vitro in RKO cell lines poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index In vivo in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93 decreases in tumor volume
This trial is to conduct a single-center Phase 1 dose escalation study of trametinib combined with HDM201 a HDM2 inhibitor in patients with advancedmetastatic RASRAF mutant and TP53 wt CRC
This trial is to conduct a single-center Phase 1 dose escalation study of trametinib combined with HDM201 a HDM2 inhibitor in patients with advancedmetastatic RASRAF mutant and TP53 wt CRC
Detailed Description:
This trial is a Phase I dose escalation study aiming to evaluate the safety of a combined treatment associating HDM201 escalating doses with Trametinib fixed dose This study will utilize sequential and adaptive Bayesian design using the method of Time-to-event Continual Reassessment Method CRM to guide dose escalation and estimate the MTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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