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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • OK-1 & Paclitaxel

    Drug

    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)

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Phase 2 CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

Overall Survival at 12 Months

Assess the percentage of patients alive at 12 months post-enrollment.

Time frame
2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: