Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02013154
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2013-12-11
Brief Title:
A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
A Multi-part Phase 1 Multi-center Open-label Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel or Pembrolizumab in Patients With Relapsed or Refractory Esophagogastric Malignancies
Status:
COMPLETED
Status Verified Date:
2023-10
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:
P102
Brief Summary:
A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies
Detailed Description:
This is a dose-escalating open-label study conducted in multiple parts Part A dose-escalation Parts B-F expansion cohorts and a monotherapy substudy Parts A-E DKN-01 plus paclitaxel and the DKN-01 monotherapy substudy includes 28-day cycle treatment cycles Part F DKN-01 plus pembrolizumab includes 21-day treatment cycles Depending on their cancer type subjects with histologically confirmed recurrent or refractory esophageal gastro-esophageal junction tumors or gastric adenocarcinoma will be enrolled in each study part to receive DKN-01 150 mg or 300 mg in combination with paclitaxel or pembrolizumab Subjects who are unable to receive paclitaxel or pembrolizumab for any reason are allowed to receive single agent DKN-01 300 mg as part of a monotherapy substudy Results are reported by treatment group irrespective of the study part in which the subject was enrolled
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DKN-01 | None | None | None |
| LY2812176 | None | None | None |
| KEYNOTE-731 | OTHER | Merck | None |