Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04681248
Status:
AVAILABLE
Last Update Posted:
2023-09-29
First Post:
2020-12-18
Brief Title:
Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
Status:
AVAILABLE
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:
None
Brief Summary:
An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors
Detailed Description:
This is a intermediate-size Expanded Access Protocol EAP Patients who were receiving DKN-01 in a parent study at the time of completion of the parent study and are in the opinion of the Investigator and Sponsor suitable candidates for continued study drug treatment are eligible for participation in the current EAP In this EAP previously treated patients will receive DKN-01 at the same dose and schedule as at the time of completion of the parent study Furthermore patients who received DKN-01 in combination in the parent study will continue to receive the same combination agent at the same dose and schedule in the EAP
DKN-01 naïve patients with advanced solid tumors not eligible for enrollment to a DKN-01 clinical study but whom in the opinion of the treating oncologist would potentially receive benefit from treatment with DKN-01 while it is an investigational drug may be eligible for enrollment in this EAP Eligible DKN-01 naïve patients with Wnt activating mutations will receive DKN-01 as monotherapy administered intravenously on Day 1 of each 21-day cycle at a dose of 600 mg with a loading dose of 600 mg of DKN-01 administered on Day 15 of Cycle 1 only
DKN-01 naïve patients with advanced solid tumors not eligible for enrollment to a DKN-01 clinical study but whom in the opinion of the treating oncologist would potentially receive benefit from treatment with DKN-01 while it is an investigational drug may be eligible for enrollment in this EAP Eligible DKN-01 naïve patients with Wnt activating mutations will receive DKN-01 as monotherapy administered intravenously on Day 1 of each 21-day cycle at a dose of 600 mg with a loading dose of 600 mg of DKN-01 administered on Day 15 of Cycle 1 only
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