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
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 94
Summary
- Conditions
- Carcinosarcoma
- Endometrial Cancer
- Ovarian Cancer
- Uterine Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 patie...
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: 300mg DKN-01 monotherapy in recurrent EEC (Group 1) 300mg DKN-01+paclitaxel in recurrent EEC (Group 2) 300mg DKN-01 monotherapy in recurrent EOC (Group 3) 300mg DKN-01+paclitaxel in recurrent EOC (Group 4) 600mg DKN-01 monotherapy in recurrent carcinosarcoma (MMMT) (Group 5) 600mg DKN-01+paclitaxel in recurrent carcinosarcoma (MMMT) (Group 6)
Tracking Information
- NCT #
- NCT03395080
- Collaborators
- Not Provided
- Investigators
- Study Director: Cynthia Sirard, MD Leap Therapeutics Principal Investigator: Rebecca Arend, MD University of Alabama at Birmingham
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