[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-leiomyosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-leiomyosarcoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100554404","phase-1-testing-the-addition-of-an-anti-cancer-drug-abemaciclib-to-the-usual-chemotherapy-treatment-gemcitabine-for-soft-tissue-sarcoma-100554404",false,"NCT06498648","Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma","Phase I\u002FII Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas","Inclusion Criteria:\n\n* Phase 1: Patients must have advanced\u002Fmetastatic histologically confirmed soft tissue sarcoma and have received at least one prior standard systemic therapy (prior gemcitabine is allowed)\n* Phase 2: Patients must have advanced\u002Fmetastatic pathologically confirmed leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is considered standard-of-care, patients may be systemic-treatment naïve. Prior gemcitabine is not allowed\n* Patients must have presence of measurable\u002Fassessable tumor\n* Patients must have intact Rb gene expression in the baseline tumor biopsy or archived tumor sample, as assessed by immunohistochemistry (at MD Anderson: clone G3- 245, BD Pharmagen, RRID:AB\\_385259, Clinical Laboratory Improvement Act \\[CLIA\\] certified antibody)\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with gemcitabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ˃ 1.2K\u002FµL\n* Hemoglobin ˃ 9.0 g\u002FdL\n* Platelets ˃ 100K\u002Fmm\\^3\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 1.5 × institutional ULN\n* Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional ULN\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\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* Patients 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 (NYHA) Functional Classification. To be eligible for this trial, patients should be class congestive heart failure (CHF) II or better\n* Patients must have a life expectancy of greater than 6 months\n* Females of childbearing potential must have a negative serum pregnancy test within one week of trial enrollment and be willing to use an adequate method of contraception to avoid pregnancy throughout the trial and for up to 6 months after the last dose of drug therapy. The effects of abemaciclib on the developing human fetus are unknown. For this reason and because CDK 4\u002F6 inhibiting agents as well as gemcitabine are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abemaciclib administration. Abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study ranging from three weeks prior to initiation of treatment and up to 6 months after the last dose of treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Patient is capable of swallowing oral medications\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents. There must be no investigational drug use within 30 days or 5 half-lives of receiving the first dose of treatment on this treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or gemcitabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because abemaciclib is a CDK4\u002F6 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib or gemcitabine, breastfeeding should be discontinued if the mother is treated with abemaciclib or gemcitabine\n* Use of strong CYP34A inhibitors which cannot be discontinued by the patient prior to trial initiation. The washout period of these drugs should be 5 half-lives\n* Progression on prior CDK4 inhibitor therapy\n* Phase 2 only: Prior gemcitabine-based chemotherapy\n* Presence of significant cardiac disease. Significant cardiac disease includes personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* Patients with interstitial lung disease (ILD)\n* Patients with gastrointestinal conditions that may affect the absorption of oral medications\n* Patients must not have received or be scheduled to receive radiation therapy within 7 days or less from gemcitabine administration\n* Patients must not have had major surgery within 14 days prior to randomization","ALL","18 Years",{"count":19,"type":20},74,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.",[27,28,29,30,31,32,33,34],"Advanced Dedifferentiated Liposarcoma","Advanced Leiomyosarcoma","Advanced Soft Tissue Sarcoma","Metastatic Dedifferentiated Liposarcoma","Metastatic Leiomyosarcoma","Metastatic Soft Tissue Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","RECRUITING","2026-06-16",{"date":38,"type":39},"2026-06-17","ACTUAL",{"date":41,"type":39},"2026-03-18",{"date":43,"type":20},"2027-01-31",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100589670","phase-1-zanzalintinib-combined-with-eribulin-in-advanced-liposarcoma-and-leiomyosarcoma-100589670","NCT06957431","Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma","A Phase I Trial of Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma","Inclusion Criteria:\n\n* Pathologically proven diagnosis of unresectable or metastatic leiomyosarcoma or adipocytic sarcoma.\n* Progressed on at least 1 line of prior therapy and have received no more than 4 lines of prior therapy.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 1\n* Adequate bone marrow and organ function within 14 days before first dose of study treatment as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm without granulocyte colony-stimulating factor support within 2 weeks of collection\n  * Platelets ≥ 100 K\u002Fcumm without transfusion within 2 weeks of collection\n  * Hemoglobin ≥ 9.0 g\u002FdL without transfusion within 2 weeks of collection\n  * INR ≤ 1.5 x ULN and aPTT ≤ 1.2 x ULN; for subjects on Factor Xa inhibitors, this criterion does not apply.\n  * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease, ≤ 3.0 x IULN)\n  * AST(SGOT)\u002FALT(SGPT)\u002Falkaline phosphatase (ALP) ≤ 3.0 x IULN (for subjects with documented bone metastasis, ALP ≤ 5.0 x IULN)\n  * Serum albumin ≥ 2.8 g\u002FdL\n  * Serum creatine ≤ 1.5 x IULN or calculated creatinine clearance ≥ 40 mL\u002Fmin by Cockcroft-Gault\n  * UPCR ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol) creatinine\n* Recovery to baseline or ≤ grade 1 from AEs, including immune-related AEs related to any prior treatments, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, ≤ grade 2 neuropathy are permitted.\n* The effects of zanzalintinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 186 days after last dose of zanzalintinib (for women) or 96 days after last dose of zanzalintinib (for men). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Pure well-differentiated liposarcoma or low grade leiomyosarcoma.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Prior treatment with zanzalintinib.\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n* Radiation therapy for bone metastasis within 2 weeks before first dose of study treatment; any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Currently receiving any other investigational agents.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression and disease is stable for at least 4 weeks before first dose of study treatment.\n\n  * Note: eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.\n  * Note: base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib or eribulin or other agents used in the study.\n* Concomitant anticoagulation with warfarin or other vitamin-K antagonists, direct thrombin inhibitors, or antiplatelet agents (e.g. clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n  * Note: subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n* Any complementary medications (e.g. herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Uncontrolled, significant intercurrent or recent illness including, but not limited to:\n\n  * Unstable or deteriorating cardiovascular disorders:\n\n    * Congestive heart failure NYHA Class 3 or 4, or Class 2 or higher unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g. ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    * Uncontrolled hypertension defined as sustained blood pressure \\> 140 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment.\n    * Stroke (including transient ischemic attack), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    * Pulmonary embolism or deep vein thrombosis or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n      * Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n      * Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the PI.\n    * Prior history of myocarditis.\n  * Gastrointestinal disorders, including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI tract from external viscera\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.\n\n      * Note: complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n    * Known gastric or esophageal varices.\n    * Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n* Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n\n  * Note: subjects with intravascular tumor extension (e.g. tumor thrombus in renal vein on inferior vena cava) may be eligible following PI approval.\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Active infection requiring systemic treatment.\n\n    * Note: prophylactic antimicrobial treatments (antibiotics, antimycotics, antivirals) are allowed.\n  * Known infection with acute or chronic hepatitis B or C, known HIV or AIDS-related illness except for subjects meeting all of the following criteria:\n\n    * On stable anti-retroviral therapy\n    * CD4+ T cell count ≥ 200\u002FμL\n    * Undetectable viral load.\n\n      * Note: HIV testing will be performed at screening if and as required by local regulation.\n      * Note: to be eligible, participants taking strong or moderate CYP inhibitors (e.g. zidovudine, ritonavir, cobicistat, didanosine) or strong or moderate CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies must have been received for at least 4 weeks prior to the first dose.\n      * Note: CD4+ T cell counts and viral load are monitored per standard of care by the local health provider.\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n\n    * Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  * Malabsorption syndrome.\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of solid organ or allogeneic stem cell transplant.\n* Major surgery (e.g. GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (e.g. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g. simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\n  * Note: fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per ECG before first dose of study treatment.\n\n  * Note: triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Inability to swallow tablets or ingest a suspension either orally or by a NG or PEG tube.\n* Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.",{"count":56,"type":20},18,[23],"The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as compared to eribulin alone based on historical data.",[28,60,61],"Adipocytic Sarcoma","Advanced Liposarcoma",[63,64,65],"Sarcoma","Eribulin","Tyrosine Kinase Inhibitor","2026-05-29",{"date":68,"type":39},"2026-06-03",{"date":70,"type":39},"2025-10-22",{"date":72,"type":20},"2036-04-30",{"name":74,"class":75},"Washington University School of Medicine","OTHER"]