Spots Global Cancer Trial Database for 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
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Trial Identification
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
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
Study ID: NCT03395080
Study Description
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-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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
HonorHealth, Scottsdale, Arizona, United States
Florida Cancer Specialists & Research Institute, West Palm Beach, Florida, United States
University of Chicago, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
HCA Midwest Health System Clinical Research, Kansas City, Missouri, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Wexner Medical Center, Hilliard, Ohio, United States
Stephenson Cancer Center - University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
The University of Tennessee West Cancer Center, Germantown, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Froedtert and Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Cynthia Sirard, MD
Affiliation: Leap Therapeutics
Role: STUDY_DIRECTOR
Name: Rebecca Arend, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
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