Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05480306
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-07-21
Brief Title:
Phase 2 Study of DKN-01 in Colorectal Cancer
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
Randomized Phase 2 Study of DKN-01 Plus FOLFIRIFOLFOX and Bevacizumab Versus FOLFIRIFOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer DeFianCe
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04681248
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
DeFianCe
Brief Summary:
This is a Phase 2 randomized open-label two-part multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRIFOLFOX and bevacizumab versus standard of care SOC FOLFIRIFOLFOX and bevacizumab as second-line treatment of advanced CRC patients
Detailed Description:
This is a Phase 2 randomized open-label two-part multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRIFOLFOX and bevacizumab versus standard of care SOC FOLFIRIFOLFOX and bevacizumab as second-line treatment of advanced CRC patients
In Parts A and B approximately 200 evaluable adult advanced CRC patients with measurable disease RECIST v11 who have radiographically progressed during or following 1 line of systemic treatment will be enrolled in the study
The study consists of a Screening Period a Treatment Period a Safety Follow-up Period SFUP and a Long-Term Follow-up Period LTFU Patients will be followed in the SFUP for approximately 30 days 7 days after the last administration of study drug and then enter the LTFU period to be followed for survival and subsequent therapies Additionally patients that ended study treatment for a reason unrelated to progressive disease PD will also be followed for disease progression in the LTFU period
In Parts A and B approximately 200 evaluable adult advanced CRC patients with measurable disease RECIST v11 who have radiographically progressed during or following 1 line of systemic treatment will be enrolled in the study
The study consists of a Screening Period a Treatment Period a Safety Follow-up Period SFUP and a Long-Term Follow-up Period LTFU Patients will be followed in the SFUP for approximately 30 days 7 days after the last administration of study drug and then enter the LTFU period to be followed for survival and subsequent therapies Additionally patients that ended study treatment for a reason unrelated to progressive disease PD will also be followed for disease progression in the LTFU period
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