[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Faeth Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100635903","phase-1-sapanisertib-and-serabelisib-piktor-in-various-combinations-in-patients-with-hrher2--advancedmetastatic-breast-cancer-100635903",false,"NCT07558733","Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of HR+\u002FHER2- breast cancer.\n* Documented evidence of advanced or recurrent disease that is not amenable to surgery\u002Fradiation for curative intent.\n* Participant has received at least one prior systemic therapy.\n* At least 1 measurable or evaluable target lesion according to RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.\n* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.\n\nExclusion Criteria:\n\n* Participants with triple-negative breast cancer.\n* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.\n* Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.\n* Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.\n* Significant cardiovascular impairment.\n* Active, uncontrolled infection.\n* Concurrent participation in another therapeutic clinical trial.\n* Prior radiation therapy within 21 days prior to start of study treatment.\n* Participants who have received a prior PI3K, AKT, mTORC1\u002F2, or dual PI3K\u002FmTOR inhibitor.\n* Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.\n* Prolongation of QTc interval to \\>480 ms.\n* Type 1 or Type 2 diabetes mellitus on insulin.","ALL","18 Years",{"count":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The study is a Phase 1b\u002F2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and\u002For other anticancer therapies in participants with HR+\u002FHER2- advanced\u002Fmetastatic breast cancer.",[27],"HR+ HER2- Breast Cancer",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"Serabelisib","Sapanisertib","Fulvestrant","Palbociclib","PI3K","mTOR","Dual PI3K\u002FmTOR inhibition","Genetic Mutation","Faslodex","SERDs","Select Estrogen Receptor Degraders","CDK","CDK46","CDK4-6","HER2-","HER2 negative","HR+","HR positive","Hormone Receptor Positive","Advanced Breast Cancer","Metastatic Breast Cancer","Recurrent Breast Cancer","Breast Cancer","Cancer of the breast","Carcinoma of the breast","Neoplasms, Breast","Metabolism","Synthetic Lethality","Metabolism Programming","PIK3CA","Oral Medications","Antineoplastic agents","AKT","RECRUITING","2026-06-30",{"date":65,"type":66},"2026-07-02","ACTUAL",{"date":68,"type":66},"2026-04-22",{"date":70,"type":20},"2033-05",{"name":72,"class":73},"Faeth Therapeutics","INDUSTRY",7,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100551664","phase-2-sapanisertib-and-serabelisib-piktor-with-paclitaxel-and-a-substudy-with-an-insulin-suppressing-diet-in-patients-with-advancedrecurrent-endometrial-cancer-100551664","NCT06463028","Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced\u002FRecurrent Endometrial Cancer","An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of endometrioid endometrial carcinoma.\n* Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery\u002Fradiation for curative intent.\n* Participant has received at least 1 but not more than 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has been unable to be treated with checkpoint inhibitor in the past due to medical contraindications, consult with Medical Monitor.\n* PI3K\u002FAKT\u002FmTOR pathway gene alteration identified.\n* At least 1 measurable target lesion according to RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.\n* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods..\n\nExclusion Criteria:\n\n* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study\n* Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.\n* Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.\n* Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding.\n* Significant cardiovascular impairment.\n* Active, uncontrolled (requiring systemic antimicrobial therapy) infection.\n* Concurrent participation in another therapeutic clinical trial.\n* Prior radiation therapy within 21 days prior to start of study treatment.\n* Strong CYP3A4 inhibitors and inducers are prohibited during the study. Strong CYP1A2 inhibitors as well as CYP1A2 inducers should be administered with caution and at the discretion of the Investigator. Alternative treatments, if available, should be considered. Additionally, strong CYP3A4 inhibitors or inducers should not be taken within 7 days before the first dose of study intervention.\n* Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH.\n* Prolongation of QTc interval to \\>480 ms.\n* HbA1c ≥ 8.0% or fasting serum glucose \\> 160 mg\u002FdL or fasting triglycerides \\> 300 mg\u002FdL or receiving treatment with insulin.","FEMALE",{"count":84,"type":20},40,[24],"This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.",[88],"Endometrial Cancer",[29,30,90,91,92,33,61,34,35,93,94,95,96,97,98,99,100,88,101,102,103,104,105,106,107,55,56,57,58,108,109,110,111,112],"Paclitaxel","Taxol","Antineoplastic Agents","Genetic mutation","Cisplatin","Carboplatin","Genital Diseases","Endometrial Neoplasms","Advanced Endometrial Carcinoma","Recurrent Endometrial Carcinoma","Metastatic Endometrial Carcinoma","Endometrioid Carcinoma","Cancer of Endometrium","Cancer of the Endometrium","Carcinoma of Endometrium","Endometrial Carcinoma","Endometrium Cancer","Neoplasms, Endometrial","PIK3CA Mutation","PI3K Gene Mutation","PI3K\u002FAKT\u002FmTOR Pathway Mutation","AKT Gene Mutation","mTOR Gene Mutation","2025-12-22",{"date":115,"type":66},"2025-12-24",{"date":117,"type":66},"2024-12-12",{"date":119,"type":20},"2029-09",{"name":72,"class":73},18,""]