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).
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, withdrawal of consent, or another clinical reason. Throughout the study, participants will undergo regular laboratory testing and clinical examinations to monitor their health and treatment response. Participation in the study is expected to last for up to one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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)
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Number and Proportion of Patients Who Safely Tolerate The Combination of OK-1 and Paclitaxel
Quantitative assessment of patients who experienced \>gr.3 AEs during OK-1 in combination with a weekly paclitaxel regimen using CTCAE v6
Time frame: 12 Months
Proportion of Patients Who Successfully Completed The Safety Lead-In Phase and Tolerated OK-1 In Combination With Paclitaxel.
Completion of safety lead-in with an established phase 2 dose for OK-1 combination with weekly intravenous paclitaxel
Time frame: 1 Year
Proportion of Participants Overrall Response Rate To OK-1 In Comination With Paclitaxel
To quantitatively evaluate the overall response rate (ORR) in the Phase 2 cohort by determining the proportion of participants who achieve a complete response (CR) or partial response (PR) to treatment.
Time frame: 2 Years
Participants Duration of Response To OK-1 In Combination With Paclitaxel
Assess the number of days from the onset of treatment-induced response to the subsequent progression of the disease or death, or last time of follow-up
Time frame: 2 years
Assess Progression Free Survival In Participants Who Tolerated OK-1 In Combination With Paclitaxel
Determine the number of days from the start of study treatment to date of imaging-confirmed study progression, death, or last time of follow-up
Time frame: 2 years
Overall Survival at 12 Months
Assess the percentage of patients alive at 12 months post-enrollment.
Time frame: 2 Years
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