[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Advenchen Laboratories, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100287066","phase-3-phase-iii-trial-of-anlotinib-catequentinib-in-advanced-alveolar-soft-part-sarcoma-leiomyosarcoma-synovial-sarcoma-apromiss-100287066",false,"NCT03016819","Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma","APROMISS","Inclusion Criteria\n\n1. Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a written informed consent form.\n2. Male or female at least 18 years of age.\n3. a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone). c. CLOSED Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma. d. CLOSED Indication D - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, and vascular origin).\n\n3\\. Open Indication E: Any sarcomas or other solid tumors 4. a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy. (New Recruitment Suspended) c. Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). d. Indication D - LMS: Treatment of patients with metastatic or advanced leiomyosarcoma (LMS) who have failed at least one prior line of standard therapy and are ineligible for or refuse standard second-line therapy or are suitable for third- and further-line treatment. Patients must have received and progressed on prior therapy and have been treated any line with an anthracycline. e. Indication E: Any sarcomas or other solid tumors such as NSCLC, SCLC and Thyroid cancer etc.: Subjects exhausted SOC treatment or refuse for any SOC treatment.\n\n5\\. Show clinical or objective disease progression after the last administration of the last standard therapy or have stopped standard therapy due to intolerability within 6 months of enrollment (excluding ASPS subjects who have not received prior therapy).\n\n6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by CT or MRI scan of the chest, abdomen and pelvis (and other areas of disease) within 28 days prior to enrollment. 8. Life expectancy of at least 3 months.\n\n9\\. Females of childbearing potential must have a negative pregnancy test (by serum beta- HCG) within 7 days prior to the start of treatment.\n\n10\\. Female of childbearing potential must be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation), abstinent (at the discretion of the investigator), or agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 2 years. Males must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) at the discretion of the investigator. 11. Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements conducted within 28 days of enrollment:\n\na. Total bilirubin \\\u003C the upper limit of normal (ULN), unless the patient has documented Gilbert's disease for which the total bilirubin should be \\\u003C 3. b. Alanine aminotransferase and aspartate aminotransferase \\\u003C 2.5 of the ULN (\\\u003C 5 x of ULN for subjects with liver involvement of their cancer) c. Amylase and lipase \\\u003C 1.5 x of ULN d. Serum creatinine \\\u003C 1.5 x of ULN e. Glomerular filtration rate \\> 30ml\u002Fmin\u002F1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula or creatinine clearance (CrCL) \\> 60 ml\u002Fmin (Cockcroft and Gault) or by 24 hour urine collection. f. International normalize ratio (INR) and the activated partial thromboplastin time (aPTT\u002FPTT) \\\u003C 1.5 x ULN. (Subjects who are therapeutically treated with an agent such LMWH or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists) g. Platelet count \\> 100,000 cells\u002Fmm3, hemoglobin \\> 9 g\u002FdL, absolute neutrophil count \\> 1,500 cells\u002Fmm3 h. Alkaline phosphatase limit \\\u003C2.5 x ULN (\\\u003C5 x ULN for subjects with liver involvement of their cancer) i. Urine protein \\\u003C 30 mg\u002FdL. If urine protein is \\> 30 mg\u002FdL, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1,000 mg per 24 hours or spot urine protein (mg\u002FdL) to creatinine (mg\u002FdL) ratio must be \\\u003C1.0.\n\n12\\. Left ventricular ejection fraction (LVEF) of \\> 50% by ECHO or MUGA within 56 days of enrollment. 13. Two readings of systolic blood pressure \\\u003C 140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg at screening taken at least 5 minutes apart in the sitting position after 5 minutes of rest. Subjects with well managed hypertension who are on oral antihypertensives must be on their current medication(s) and stable dose(s) for at least 2 weeks prior to enrollment.\n\nExclusion Criteria\n\n1. Prior treatment with or have known hypersensitivity to AL3818.\n2. a. Indication A - ASPS: Prior treatment with cediranib. b. Indication B - LMS: Prior treatment with or have known hypersensitivity to dacarbazine. (New Recruitment Suspended) c. Indication C - SS: Prior treatment with or have known hypersensitivity to dacarbazine.\n\n   d. Indication D - LMS: Prior treatment with anlotinib.\n3. Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LMS, or SS within 5 years before enrollment except for successfully treated in situ carcinoma, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1).\n4. Received last dose of systemic cytotoxic therapy or investigational therapy within 21 days of enrollment or last dose of hormonal therapy, immunotherapy, targeted therapy or any other type of non-cytotoxic anti-cancer therapy within 14 days of enrollment.\n5. Prior treatment with extended-field radiotherapy (EFRT) within 28 days of enrollment or prior treatment with any other form of radiotherapy within 14 days of enrollment.\n6. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided that they are stable with no evidence of progression by imaging, and all neurologic symptoms have returned to baseline, and should not be using corticosteroids for at least 7 days prior to study treatment.\n7. Cavitary tumors or tumors invading or abutting large blood vessels in the thorax.\n8. History of gastrointestinal perforation, abdominal fistula or intra-abdominal abscess within 6 months of enrollment.\n9. Known history of bleeding disorders (e.g., von Willebrand disease or hemophilia).\n10. Clinically significant bleeding such as gross hematuria, gastrointestinal bleeding and hemoptysis within 6 months prior to enrollment.\n11. CTCAE version 4.03 \\> grade 2 pulmonary hemorrhage or \\> grade 3 of other forms of bleeding within 28 days prior to enrollment.\n12. History of untreated deep venous thrombosis (DVT) within the past 6 months. Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin which is exclusionary) for at least 14 days prior to start of study treatment.\n13. Use of aspirin (\\>325 mg\u002Fday) within 10 days prior to the first dose of study treatment.\n\n    The use of prophylactic therapeutic anti-coagulants are allowed provided that INR or aPTT are within therapeutic limits (according to the medical standard of the enrollment institution) and patient has been on a stable dose of anticoagulants for at least two weeks prior to the first dose of study treatment.\n14. Serious non-healing wound, active ulcer.\n15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment or minor surgical procedure within 7 days of enrollment.\n16. CTCAE version 4.03 \\> grade 3 peripheral neuropathy\n17. Any unrecovered toxicity reactions of CTCAE version 4.03 \\> grade 1 caused by any previous therapy (excluding alopecia and neurotoxicity \\\u003C grade 2)\n18. QTcF \\> 470 msec (per Fridericia's formula) on electrocardiogram within 28 days of enrollment.\n19. Severe and uncontrolled disease, including:\n\n    1. Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure classified according to New York Heart Association (NYHA)\n    2. Active or failed to control serious infections (CTCAE version 4.03 \\> grade 2 infections)\n    3. Liver disease such as cirrhosis of the liver, decompensated liver disease, chronic active hepatitis needing anti-viral therapy\n    4. Renal failure needing hemodialysis or peritoneal dialysis\n    5. Poorly controlled diabetes (HgA1C \\>8)\n    6. Untreated and uncontrolled epileptic seizures\n    7. History of psychotropic drug abuse and inability to quit\n    8. Untreated psychiatric disorders\n20. Known HIV-positive\n21. Had organ transplantation\n22. Clinical conditions affecting the intake and use of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction)\n23. Females who are pregnant or are breast-feeding.\n24. Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5; or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19; or QT prolongating medications within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.\n25. Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.","ALL","18 Years",{"count":20,"type":21},325,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA.\n\nThis study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.",[27,28,29,30],"Alveolar Soft Part Sarcoma","Leiomyosarcoma","Synovial Sarcoma","Soft-Tissue Sarcoma","RECRUITING","2026-02-23",{"date":34,"type":35},"2026-02-25","ACTUAL",{"date":37,"type":35},"2017-08-15",{"date":39,"type":21},"2028-12",{"name":41,"class":42},"Advenchen Laboratories, LLC","INDUSTRY",24,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100623138","phase-1-a-phase-iiia-study-of-al8326-combined-with-toripalimab-in-the-treatment-of-advanced-solid-tumors-100623138","NCT07392736","A Phase I\u002FIIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.","A Phase I\u002FIIa Clinical Trial of AL8326 Tablets Combined With Toripalimab in the Treatment of Advanced Recurrent or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Subjects must be able to understand and voluntarily sign a written informed consent form prior to the initiation of any study-related procedures.\n2. Age ≥ 18 years.\n3. Subjects with histologically confirmed advanced recurrent or metastatic solid tumors who meet one of the following conditions:\n\n   1. Failure of standard therapy (disease progression after treatment or intolerance to treatment toxicity);\n   2. no effective treatment available.\n   3. Toripalimab monotherapy as a second-line or later standard treatment.\n4. Must have at least one measurable lesion as defined by RECIST 1.1.\n5. Prior cytotoxic chemotherapy must have been completed at least 4 weeks before enrollment, and any toxicities must have recovered to ≤ Grade 1 (except alopecia).\n6. Life expectancy of ≥ 12 weeks at the time of enrollment.\n7. ECOG performance status of 0 or 1.\n8. Adequate organ function:\n\n   1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (1500\u002Fmm³); Platelets ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 9.0 g\u002FdL.\n   2. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n   3. Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for subjects with Gilbert's syndrome); AST and ALT ≤ 2.5 × ULN in subjects without liver metastases, or ≤ 5 × ULN in subjects with liver metastases.\n   4. Coagulation function: International normalized ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Left ventricular ejection fraction (LVEF) \\> 50% during screening.\n10. Systolic blood pressure \\\u003C 140 mmHg and diastolic blood pressure \\\u003C 90 mmHg (without medication or controlled with a single agent).\n11. Females: Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must agree to use medically acceptable methods of contraception during the treatment period and for 3 months after the last dose; The patient must be non-lactating; Postmenopausal women (≥ 12 months of amenorrhea without other causes) or surgically sterilized (oophorectomy and\u002For hysterectomy) are not considered of childbearing potential. Their partners must use medically acceptable contraception during the treatment period and for 3 months after the last dose. Males: Surgically sterile or must agree to use medically acceptable contraception during the treatment period and for 3 months after the last dose; Their partners must use medically acceptable contraception during the same period.\n12. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.\n\nExclusion Criteria\n\n1. Received systemic cytotoxic therapy or investigational therapy within 28 days prior to initiation of study treatment, or non-cytotoxic, non-investigational therapy (e.g., radiotherapy, hormone therapy, targeted therapy, immunotherapy) within 14 days prior to initiation of study treatment.\n2. Major surgery (defined as requiring general anesthesia within 28 days before initiation of study treatment, or minor surgery requiring general anesthesia within 7 days before initiation of study treatment).\n3. Pregnant or lactating women.\n4. History of prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of safety or efficacy of the study treatment.\n5. Subjects with active or untreated central nervous system (CNS) metastases; Subjects with stable brain metastases may be enrolled if they meet the following criteria: a) No radiological evidence of progression for ≥ 4 weeks after completion of treatment; b) Completion of treatment ≥ 28 days before the first dose of study drug; c) No requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within ≤ 14 days prior to the first dose of study drug.\n6. Active, known, or suspected autoimmune disease or interstitial lung disease.\n7. Requirement for systemic therapy with corticosteroids or other immunosuppressive drugs within 14 days prior to initiation of study treatment.\n8. Peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with risk of perforation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to initiation of study treatment.\n9. Untreated deep vein thrombosis (DVT) within the past 6 months. Subjects with DVT treated with therapeutic anticoagulants (excluding therapeutic warfarin) for at least 14 days prior to initiation of study treatment are allowed.\n10. Uncontrolled infection.\n11. New York Heart Association (NYHA) Grade III or greater congestive heart failure.\n12. History of any of the following cardiac conditions within 6 months prior to initiation of study treatment:\n\n    1. Cardiac angioplasty or stenting;\n    2. Myocardial infarction;\n    3. Unstable angina;\n    4. Cerebrovascular accident.\n13. Presence of any unhealed wound, fracture, or ulcer, or symptomatic peripheral vascular disease.\n14. Evidence of hemorrhagic diathesis, coagulation disorder, or clinically significant bleeding (e.g., severe hematuria, gastrointestinal bleeding, hemoptysis) within 6 months prior to initiation of study treatment.\n15. QTcF ≥470 msec on screening ECG per Fridericia's formula.\n16. Urinalysis showing urine protein ≥ ++ and 24-hour urine protein quantification \\> 1.0 g within 28 days prior to initiation of study treatment.\n17. Positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the lower limit of detection of the local laboratory; Positive hepatitis C antibody (anti-HCV) with HCV-RNA above the lower limit of detection of the local laboratory; Positive syphilis antibody; Positive human immunodeficiency virus (HIV) antibody test.\n18. History of organ transplantation.\n19. Clinical conditions affecting the intake or absorption of AL8326 (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, malabsorption disorders, gastrectomy or small bowel resection).\n20. Use of prohibited concomitant medications within 14 days prior to initiation of study treatment.\n21. Receipt of red blood cell or platelet transfusion within 14 days prior to initiation of study treatment.\n22. Known allergy, hypersensitivity, or intolerance to protein therapies, or history of any severe drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia).\n23. Any severe and\u002For unstable pre-existing medical, psychiatric, or other condition that may jeopardize subject safety, obtaining informed consent, compliance with study procedures, or achievement of study objectives.",{"count":52,"type":21},228,[54,55],"PHASE1","PHASE2","This trial is an open, non-randomized, phase I\u002FIIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors",[58],"Solid Tumor","2026-02-03",{"date":61,"type":35},"2026-02-06",{"date":63,"type":35},"2021-10-26",{"date":65,"type":21},"2029-11-07",{"name":41,"class":42},15,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":84,"locationsCount":4},"100486293","catequentinib-in-patients-who-have-completed-an-advenchen-study-a-compassionate-use-trial-100486293","NCT05612191","Catequentinib in Patients Who Have Completed an Advenchen Study (A Compassionate Use Trial)","An Open Label Post-Trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride Mono or in Combination Therapies in Patients Who Have Completed an Advenchen Sponsored Oncology Study With AL3818 (A Compassionate Use Trial)","Inclusion Criteria:\n\n* Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients.\n* Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.\n* Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.\n* Patient is willing and able to sign a new informed consent.\n* Patients for whom the Investigator believes can benefit from continuing to receive AL3818\n\nExclusion Criteria:\n\n* Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial.\n* Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.","EXPANDED_ACCESS","Catequentinib (AL3818, Anlotinib) has been developed in a variety of clinical studies as single agents or in combination with others. This trial is designed to offer patients who completed an Advenchen sponsored AL3818 related study without progression the opportunity to continue to receive this investigational product in this Post-Trial Access study (a compassionate use trial), if the Investigator believes the patients can benefit from such a treatment and the patients have signed the Informed Consent Form.",[78,79],"Sarcoma,Soft Tissue","Gynecologic Cancer","AVAILABLE","2022-11-22",{"date":83,"type":35},"2022-11-28",{"name":41,"class":42},""]