Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03829410
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2019-02-01
Brief Title:
Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a Kras Mutation
Sponsor:
Cardiff Oncology
Organization:
Cardiff Oncology
Study Overview
Official Title:
A Phase 1b2 Study of Onvansertib PCM-075 in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a Kras Mutation
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The purpose of the Phase 1b2 study is to determine the safety and efficacy of Onvansertib administered orally daily on Day 1-5 and Day 15-19 of each 28-day cycle in combination with FOLFIRI Bevacizumab as second-line treatment in adult participants who have metastatic colorectal cancer with a Kras mutation Participants must have histologically confirmed metastatic and unresectable disease and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab
Detailed Description:
None
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