Evaluating the Addition of OK-1 Weekly Paclitaxel in Patients With Endometrial Cancer
ConditionEndometrial Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Oklahoma
About this trial
The purpose of this study is to evaluate whether treatment with the investigational drug OK-1 in combination with paclitaxel can reduce tumor burden in patients with advanced or recurrent endometrial cancer (A/R-EC).
Eligibility criteria
Qualifiers
At least 18 years-of-age at the time of signature of the informed consent form (ICF).
Histologically documented carcinoma of the endometrium, including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed, or is refractory to curative therapy or established treatments.
Must have pre-treatment archival tissue.
Measurable disease by RECIST v1.1 is required for the phase 2 portion of the study. Patients with accessible disease are eligible for the safety lead in cohorts. Patients with biochemical recurrent disease only (ie Ca125 elevation or ctDNA elevation in absence of visible disease on CT scan are NOT eligible)
Disqualifiers
Patients who have received prior weekly paclitaxel for recurrent endometrial cancer.
Major surgical procedure within 28 days prior to registration, or anticipation of need for major surgical procedure during the study. Note: Placement of a vascular access device, thoracentesis, and/or paracentesis will not be considered major surgery.
Women who are pregnant or are unwilling to discontinue nursing.
Evidence of bleeding diathesis or clinically significant coagulopathy within the past 3 months. Patients are not excluded for past or current use of anticoagulation.
Trial design
Treatments tested in this trial
- OK-1 & Paclitaxel
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Oklahoma
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov