Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03395080
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2018-01-02
Brief Title:
A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma
Sponsor:
Leap Therapeutics Inc
Organization:
Leap Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial Epithelial Ovarian Cancer or Carcinosarcoma
Status:
COMPLETED
Status Verified Date:
2023-05
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:
P204
Brief Summary:
A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination with Paclitaxel in Patients With Recurrent Epithelial Endometrial Cancer Epithelial Ovarian Cancer or Carcinosarcoma
Detailed Description:
This study employs a basket design to concurrently investigate DKN-01 as monotherapy and in combination with paclitaxel in patients with recurrent epithelial endometrial cancer EEC epithelial ovarian cancer EOC or carcinosarcoma malignant mixed Mullerian tumor MMMT Thus 6 distinct patient groups are being independently investigated
1 300mg DKN-01 monotherapy in recurrent EEC Group 1
2 300mg DKN-01paclitaxel in recurrent EEC Group 2
3 300mg DKN-01 monotherapy in recurrent EOC Group 3
4 300mg DKN-01paclitaxel in recurrent EOC Group 4
5 600mg DKN-01 monotherapy in recurrent carcinosarcoma MMMT Group 5
6 600mg DKN-01paclitaxel in recurrent carcinosarcoma MMMT Group 6
1 300mg DKN-01 monotherapy in recurrent EEC Group 1
2 300mg DKN-01paclitaxel in recurrent EEC Group 2
3 300mg DKN-01 monotherapy in recurrent EOC Group 3
4 300mg DKN-01paclitaxel in recurrent EOC Group 4
5 600mg DKN-01 monotherapy in recurrent carcinosarcoma MMMT Group 5
6 600mg DKN-01paclitaxel in recurrent carcinosarcoma MMMT Group 6
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