[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aids-related-kaposi-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aids-related-kaposi-sarcoma":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634420","phase-2-nirogacestat-in-patients-with-kaposi-sarcoma-100634420",false,"NCT07539454","Nirogacestat in Patients With Kaposi Sarcoma","Phase II Study of Nirogacestat in Patients With Kaposi Sarcoma","Inclusion Criteria:\n\n* Biopsy-proven KS involving skin with or without visceral involvement either newly diagnosed or refractory to or intolerant of one or more prior therapies.\n* Patients must have cutaneous lesion(s) amenable to six total biopsies (minimum size of biopsy to be 4 mm), either six lesions \\> 4 mm or one large lesion measuring 20 mm that can undergo serial biopsy, and at least five additional lesions measurable for assessment with no improvement over the past month.\n* Hemoglobin ≥ 8 g\u002FdL (within three months prior to study entry)\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm\\^3 (within three months prior to study entry)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (within three months prior to study entry)\n* Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (within three months prior to study entry) (CrCl may also be obtained by the 24-hour collection method at the investigator's discretion)\n* Total bilirubin should be ≤ 1.5x upper limit of normal (ULN) (within three months prior to study entry). If, however, the elevated bilirubin is felt to be secondary to atazanavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is ≤ 3.5 mg\u002FdL provided that the direct bilirubin is normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3x ULN (within three months prior to study entry)\n* Life expectancy ≥ 3 months.\n* Ability and willingness to give informed consent.\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test defined as serum Estradiol (E2) \\> 30 pg\u002FmL, a serum follicle stimulating hormone (FSH) \\\u003C 40 mIU\u002FL (measured on Day 3 in regularly menstruating females and age-matched), within 10-14 days prior and again within 24 hours of starting nirogacestat. FCBP must either commit to continued abstinence from heterosexual intercourse or the use of two acceptable methods of birth control, one highly effective method except oral contraceptives and one additional effective method at the same time , at the start of therapy to 7 days after discontinuation of nirogacestat, inclusive. Females and males of reproductive potential will be advised to use effective contraception during treatment with nirogacestat and for 7 days after the last dose. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Patients must, in the opinion of the investigator, be capable of complying with the protocol.\n\n  * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* All patients with HIV must be on antiretroviral therapy (ART) for HIV infection with CD4 count \\> 50\u002Fmm\\^3 and viral load \\\u003C 200 copies\u002FmL. Patients must be on a stable regimen for at least 12 weeks prior to study entry. Patients may receive any Food and Drug Administration (FDA) approved ART except for zidovudine or protease inhibitors.\n* There should be no evidence for improvement in KS in the 3 months prior to study entry for all participants, unless there is evidence for progression of KS in the 4 weeks immediately prior to study entry.\n* If antiretroviral regimen contains zidovudine, efavirenz, etravirine, or protease inhibitors and viral load is suppressed (as measured by HIV viral load ≤ 200\u002FmL), then ART must be adjusted to a less toxic therapy not containing these antivirals and enrollment may proceed without waiting 12 weeks. If on antiviral therapy with zidovudine, efavirenz, etravirine, or protease inhibitors, and viral load is not suppressed (as measured by HIV viral load ≥ 200\u002FmL), then ART must be adjusted to a less toxic regimen allowing for optimal viral suppression and must demonstrate stability for at least 12 weeks prior to study entry.\n* If HIV positive, documentation of HIV-1 or HIV-2 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care provider.\n  * Documentation of receipt of ART (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name.\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\> 200 RNA copies\u002FmL.\n  * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as an HIV-1 Western blot confirmation or HIV rapid multi-spot antibody differentiation assay.\n* Age ≥ 18 years. No dosing or adverse event (AE) data are currently available on the use of nirogacestat in participants \\\u003C 18 years of age; children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).\n* Participants with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 3 months before study enrollment. To be eligible for this trial, participants must be Class II or better within 3 weeks before enrollment.\n\nExclusion Criteria:\n\n* Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment.\n* Patients for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status).\n* Concurrent neoplasia requiring cytotoxic therapy.\n* Anti-neoplastic treatment for KS (including chemotherapy, radiation therapy, local therapy including topical 5-FU, biological therapy, or investigational therapy) within four weeks of study entry.\n* Any ongoing glucocorticoid treatment (within last three months, lasting longer than 14 days) except for that required for replacement therapy in adrenal insufficiency or inhaled glucocorticoids for the treatment of asthma.\n* Any steroid treatment with equivalent of more than 10 mg prednisone\u002Fday lasting longer than 14 days in the last 3 months.\n* Patient is ≤ 2 years free of another primary malignancy. Exceptions include the following:\n\n  * Basal cell skin cancer.\n  * Cervical carcinoma in situ.\n  * Anal carcinoma in situ.\n* Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since treatment. Any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion.\n* Use of any investigational drug or treatment within four weeks prior to enrollment.\n* Physical or psychiatric conditions that in the estimation of the investigator place the patient at high risk of toxicity or non-compliance.\n* Female patients who are pregnant, lactating, or breast-feeding.\n* Patients requiring blood transfusions to maintain hemoglobin eligibility.\n* Patients currently receiving zidovudine, protease inhibitors, efavirenz, etravirine, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, St John's Wort, tacrolimus, cyclosporine, oral contraceptives, warfarin, docetaxel, sirolimus, or other inhibitors or inducers of CYP3A4 or substrates of CYP3A4 that have a narrow therapeutic margin.\n* Patients with CD4 \\\u003C 50 mm\\^3 and\u002For viral load ≥ 200 copies\u002FmL.\n* HIV+ patients with corrected QT interval by Fridericia's formula (QTcF) \\> 480 ms.","ALL","18 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.",[26,27],"AIDS-Related Kaposi Sarcoma","Skin Kaposi Sarcoma","NOT_YET_RECRUITING","2026-05-27",{"date":31,"type":32},"2026-05-28","ACTUAL",{"date":34,"type":20},"2026-09-17",{"date":36,"type":20},"2030-02-17",{"name":38,"class":39},"AIDS Malignancy Consortium","NETWORK",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100470851","phase-3-paclitaxel-and-pegylated-liposomal-doxorubicin-for-treatment-of-hiv-related-kaposi-sarcoma-100470851","NCT05411237","Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma","A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings","Inclusion Criteria:\n\n1. HIV-1 infection.\n2. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.\n3. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR\n\n   Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either:\n   * 20 or more skin and\u002For oral KS lesions, and\u002For\n   * any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization).\n4. Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons \\\u003C18 years of age, children are excluded from this study\n5. Karnofsky performance status ≥ 60 (ECOG ≤ 2).\n6. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%.\n7. Ability and willingness of participant or legal guardian to provide informed consent.\n8. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression.\n9. Measurable cutaneous KS, defined as follows:\n\n   * When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions.\n   * If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2.\n10. The following laboratory values obtained within 14 days prior to study entry:\n\n    * Absolute Neutrophil Count ≥ 1000 cells\u002Fmm3.\n    * Hemoglobin ≥ 8 g\u002FdL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator).\n    * Platelet count ≥ 75,000\u002Fmm3.\n    * ALT, AST, Alkaline phosphatase \\\u003C 5 × upper limit of normal (ULN).\n    * Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN.\n    * Creatinine \\\u003C institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n11. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication.\n12. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication.\n13. Adequate venous access.\n14. No prior chemotherapy or use of systemic cytotoxic therapy agents.\n15. Participant is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and\u002For is not clinically stable.\n2. Serious illness necessitating hospitalization\u002Fsystemic treatment within 14 days prior to study entry\n3. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.\n4. Known history of congestive heart failure and\u002For systolic ejection fraction \\\u003C 50%.\n5. Prior radiotherapy to KS indicator lesions\n6. Prior or current immunotherapy\n7. Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19\u002FSARS-CoV-2, which are permitted.\n8. Known allergy\u002Fhypersensitivity to the study drug or its formulation\n9. Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n10. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.\n11. Patients with psychiatric illness and\u002For social circumstances that would limit compliance with study requirements.",{"count":49,"type":20},130,[51],"PHASE3","This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.",[54,55,56],"Kaposi Sarcoma","HIV-1-infection","AIDS-related Kaposi Sarcoma",[58,59,60,61,62],"Paclitaxel","Pegylated liposomal doxorubicin","AIDS associated Kaposi Sarcoma","Human Immunodeficiency Virus","HIV-related Kaposi Sarcoma","2026-01-22",{"date":65,"type":32},"2026-01-23",{"date":67,"type":20},"2026-09",{"date":69,"type":20},"2030-09",{"name":38,"class":39}]