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 or Epithelial Ovarian Cancer

Protocol: 
AAAS0164
Phase: 
II

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 or Epithelial Ovarian Cancer

This research study is a Phase 2 clinical trial designed to evaluate the
activity of DKN-01, an investigational drug, either in combination with
paclitaxel or as a monotherapy in participants with recurrent endometrial or
ovarian cancer who have received at least one prior systemic therapy for
advanced disease. “Investigational” means that the drug is being studied.
It also means that the FDA (U.S. Food and Drug Administration) has not
approved DKN-01 for use in participants, including people with your type of
cancer.

Your participation in this study may help to learn more about how safe the
combination of DKN-01 with paclitaxel is, how DKN-01 and paclitaxel work
together, and how DKN-01 works as a single agent in participants not able to
receive paclitaxel.

Are you Eligible? (Inclusion Criteria)

1. Must have a histologically confirmed diagnosis (by either primary
surgical specimen or biopsy for recurrence) of recurrent previously treated
Epithelial Endometrial Cancer or histologically confirmed diagnosis (by
either primary surgical specimen or biopsy for
recurrence) of recurrent platinum-resistant/refractory Epithelial Ovarian
Cancer (i.e., disease recurrence within 6 months of completion of or
progression during platinum-based chemotherapy).
2. Tumor tissue for mandatory pre-treatment and on–treatment evaluation
(fresh biopsy during Screening preferred; archived specimen (≤3 months)
3. Must be intolerant to at least one prior standard therapy(ies) for
metastatic or locally advanced disease.
4. One or more tumors measurable on radiographic imaging

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States