A Single Arm Phase 2 Trial With a Safety Lead in Evaluating the Addition of OK-1 to Weekly Paclitaxel in Patients With Recurrent Endometrial Cancer
University of Oklahoma
Summary
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).
Description
Participants will receive OK-1 capsules by mouth twice daily in continuous 21-day treatment cycles. Paclitaxel will be administered by intravenous (IV) infusion once weekly during each 21-day cycle. A combined total of 66 patients will participate in this study, with the initial safety lead-in cohort involving 30 patients, followed by 36 new patients enrolled in the phase 2 arm. Treatment cycles will continue until the participant, the treating physician, or the study team determines that continued participation is no longer appropriate due to disease progression, unacceptable side effects, w…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 th…
Interventions
- DrugOK-1 & Paclitaxel
OK-1 capsules will be administered orally at 3.5-4.5 mg/kg twice a day during a 21-day cycle (3 weeks on, one week off in a 28-day cycle) Other Names: • NSC 726189 Paclitaxel will be administered 60-70 mg/m2 IV on Day 1,8 and 15 (3 weeks on, one week off in a 28-day cycle)
Location
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma