Trials / Completed
CompletedNCT03395080
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
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Leap Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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-01+paclitaxel in recurrent EEC (Group 2) 3. 300mg DKN-01 monotherapy in recurrent EOC (Group 3) 4. 300mg DKN-01+paclitaxel in recurrent EOC (Group 4) 5. 600mg DKN-01 monotherapy in recurrent carcinosarcoma (MMMT) (Group 5) 6. 600mg DKN-01+paclitaxel in recurrent carcinosarcoma (MMMT) (Group 6)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | Administered by IV infusion |
| DRUG | 300mg DKN-01 | Administered by IV infusion |
| DRUG | 600mg DKN-01 | Administered by IV infusion |
Timeline
- Start date
- 2018-03-05
- Primary completion
- 2020-09-09
- Completion
- 2021-01-27
- First posted
- 2018-01-10
- Last updated
- 2025-08-01
- Results posted
- 2023-06-09
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03395080. Inclusion in this directory is not an endorsement.