[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649526":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2 Cohort","EXPERIMENTAL","OK-1 (oral, BID) 28-days cycle. Weekly Paclitaxel (IV) 21-days cycle.",[13],"Drug: OK-1 & Paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","OK-1 & Paclitaxel","OK-1 capsules will be administered orally at 3.5-4.5 mg\u002Fkg twice a day during a 21-day cycle (3 weeks on, one week off in a 28-day cycle)\n\nOther Names:\n\n• NSC 726189\n\nPaclitaxel will be administered 60-70 mg\u002Fm2 IV on Day 1,8 and 15 (3 weeks on, one week off in a 28-day cycle)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Kathleen Moore, MD","Nebraska Medical Center","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lead Gynecology Oncology Nurse","CONTACT","572-244-0111","SCC-IIT-Office@ouhsc.edu",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73117","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-97.51643,35.46756,{"lat":44,"lon":43},[47],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":48},"Katmoore@unmc.edu",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"National Cancer Institute (NCI)","NIH","100649526","phase-2-evaluating-the-addition-of-ok-1-weekly-paclitaxel-in-patients-with-endometrial-cancer-100649526",false,"NCT07737795","Evaluating the Addition of OK-1 Weekly Paclitaxel in Patients With Endometrial Cancer","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","Inclusion Criteria:\n\n* At least 18 years-of-age at the time of signature of the informed consent form (ICF).\n* 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.\n* Must have pre-treatment archival tissue.\n* 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)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Adequate organ function, defined in study protocol.\n* Prior therapy: Patients must have received ≥1 platinum-based therapy in the recurrent\u002Fmetastatic setting and not more than 5 prior lines of therapies.\n\n  * Adjuvant therapy given for early stage, high risk endometrial cancer does NOT count as the line of qualifying platinum based chemotherapy unless disease recurrence is documented \\\u003C 12 months from completion. If \\>12 months has elapsed, patients should receive another line of platinum based chemotherapy.\n  * Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase \\[PARP\\] inhibitor, endocrine therapy or immune checkpoint inhibitor will be considered part of the preceding line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently)\n  * Hormonal therapy will not be counted as a separate line of therapy.\n  * Patients should have received an immune checkpoint inhibitor as part of a prior line of therapy unless contraindicated to participate in this trial.\n  * If the Patient has a tumor that is HER2 3+, trastuzumab deruxtecan should have been used unless ineligible.\n  * During the course of this clinical trial, if an antibody drug conjugate becomes available therapy for recurrent endometrial cancer, patients should be treated with that therapy unless ineligible\n* The patient must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.\n* QTcF \\\u003C 470 msec\n\nExclusion Criteria:\n\n* Patients who have received prior weekly paclitaxel for recurrent endometrial cancer.\n* 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\u002For paracentesis will not be considered major surgery.\n* Women who are pregnant or are unwilling to discontinue nursing.\n* Evidence of bleeding diathesis or clinically significant coagulopathy within the past 3 months. Patients are not excluded for past or current use of anticoagulation.\n* There is no prespecified washout from prior therapies.\n* Patients with adverse events related to prior therapies must have resolution to \\\u003C grade 1. Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. Note: Grade 2 neuropathy is neuropathy on one medication so patients may be eligible following discussions with the medical monitor.\n\nAdditional exceptions include immune-related AEs such as adrenal insufficiency, hypothyroidism (controlled), endocrine-related toxicities due to checkpoint inhibitor treatment (can be corrected through hormone replacement therapy) and Grade 2 laboratory abnormalities that meet the eligibility requirements.\n\n* Patients currently taking and unwilling\u002Funable to discontinue the use of drugs that are known to be strong\u002Fmoderate inhibitors or inducers of CYP3A4, CYP2C8, CYP2C19, and CYP2C9. (Refer to Appendix III)\n* Comorbid Conditions: No active infection requiring parental antibiotics except for urinary tract infection.\n* No evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula, gastrointestinal perforation, or GI obstruction requiring gastrostomy tube. NOTE: required interval since last bowel obstruction: 30-day minimum for incomplete obstruction, resolved with conservative means; 6 months for fistula. Patients with a history of a large bowel obstruction that has been successfully diverted and do not meet the criteria for small bowel obstruction are eligible.\n* Patients with risk factors for torsade de pointes (TdP) such as clinically significant heart failure (defined as a known ejection fraction \\\u003C 50%), uncorrected grade 2 or greater hypokalemia, family history of long QT syndrome )","FEMALE","18 Years",{"count":65,"type":66},66,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","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\u002FR-EC).",[72],"Endometrial Cancer",[74,75,76],"OK-1","A\u002FR-EC","ShetA2","NOT_YET_RECRUITING","2026-07-27",{"date":80,"type":81},"2026-07-30","ACTUAL",{"date":83,"type":66},"2026-08",{"date":85,"type":66},"2029-08",{"name":5,"class":6},1]