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
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
University of Alabama
Birmingham, Alabama, United States
HonorHealth
Scottsdale, Arizona, United States
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
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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
...and 7 more locations
Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
Time frame: Baseline to study completion (maximum 17.6 months)
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
Time frame: Baseline to study completion (maximum 7.1 months)
Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.
Time frame: Baseline to study completion (approximately 11 months)
Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.
Time frame: Baseline to study completion (approximately 11 months)
Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.
Time frame: Baseline to study completion (approximately 13.1 months)