A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent E… (NCT03395080) | Clinical Trial Compass
CompletedPhase 2
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
United States111 participantsStarted 2018-03-05
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Diagnosis:
✓. Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC.
✓. Epithelial Ovarian Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent platinum-resistant/refractory EOC, primary peritoneal, or fallopian tube cancer (i.e., disease recurrence within 6 months of completion of or progression during platinum-based chemotherapy).
✓. Carcinosarcoma/Malignant Mixed Mullerian Tumors: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent uterine or ovarian carcinosarcoma (MMMT). Patients must have had only 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have been included chemotherapy (including in adjuvant setting), chemotherapy and radiotherapy, and/or consolidation/maintenance therapy.
✓. Refractory or intolerant to at least one prior standard therapy(ies) for metastatic or locally advanced disease (see Inclusion Criterion #1c for Groups 5-6).
✓. If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy.
✓. Prior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel.
✓. Patients who are not eligible to receive paclitaxel will be allowed to receive single agent DKN-01.
Exclusion criteria
✕. Patients with the following pure histologies of endometrial or ovarian cancer are not eligible for enrollment: germ cell, sex cord stroma, or sarcoma.
What they're measuring
1
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Timeframe: Baseline to study completion (approximately 6 months)
2
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Timeframe: Baseline to study completion (approximately 6 months)
✕. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
✕. Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or history of congenital long QT syndrome.
✕. Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
✕. Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb), unless hepatitis C virus ribonucleic acid (HCV RNA) undetected/negative.
✕. History of major organ transplant (i.e., heart, lungs, liver, or kidney).
✕. History of autologous/allogenic bone marrow transplant.