[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioLite, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100349699","phase-1-a-phase-iii-study-of-pdc-1421-for-treating-depression-in-cancer-patients-100349699",false,"NCT03833206","A Phase I\u002FII Study of PDC-1421 for Treating Depression in Cancer Patients","A Phase I\u002FII Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation","Eligibility Criteria\n\n* 21 to 85 Years of age\n* Diagnosis of Stage I, II or III cancer\n* Histologically-proven malignancy\n* Receiving or within one year of having received cancer treatment with radiation and\u002For chemotherapy\n* Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms)\n* Duration of depressive symptoms ≥ 2 weeks by patient report.\n* No active\u002Facute suicidality requiring immediate care or psychiatric hospitalization\n* Sufficient English language proficiency to complete all assessments without assistance\n* Able to swallow pills\n* No severe anemia, defined as hemoglobin \\\u003C 10 g\u002FdL\n* No history of multiple adverse drug reactions or allergy to study drugs\n* Not pregnant\n* No history of head trauma\n* No history of epilepsy\n* No other concurrent antidepressant medications\n\nExclusion Criteria\n\n* Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus).\n* Have a documented history of an intellectual disability.\n* Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).\n* Currently being treated with tamoxifen.\n* Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage\\* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.\n* Have a history of any seizure disorder.\n* Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.\n* Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:\n\n  1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and\u002For\n  2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.\n* Have a history of substance dependence\u002Fabuse\\*\\* within the past 6 months or a positive drug screen result during the screening period.\n* Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.\n* \\* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg\u002Fday) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg\u002Fday, the adequate dosage is 40 mg\u002Fday.\n* \\*\\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and\u002For with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg\u002FdL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg\u002FdL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg\u002FdL is to be excluded.","ALL","21 Years","85 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.",[28],"Major Depressive Disorder","NOT_YET_RECRUITING","2026-04-15",{"date":32,"type":33},"2026-04-20","ACTUAL",{"date":35,"type":21},"2027-01-15",{"date":37,"type":21},"2028-02-28",{"name":39,"class":40},"BioLite, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100281551","phase-2-a-study-of-blex-404-oral-liquid-in-patients-with-international-prognostic-scoring-system-ipss-intermediate-1-intermediate-2-or-high-risk-myelodysplastic-syndrome-mds-and-chronic-myelomonocytic-leukemia-cmml-100281551","NCT02944955","A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)","Inclusion Criteria:\n\n* Age 20 or older, able to sign informed consent, understand and comply with protocol requirements and instructions.\n* Body weight between 30 to 120 kg\n* International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2) or high-risk myelodysplastic syndrome (MDS) by World Health Organization (WHO) or Chronic Myelomonocytic Leukemia (CMML) patients.\n* Not previously treated with MDS and CMML therapy and require treatment with azacitidine\\* for the first time at 75 mg\u002Fm2 subcutaneously or intravenously, daily for 7 days (7 nonconsecutive day of 6-1-1 or 5-2-2 treatment schedule is acceptable in which the drug is administered Monday-Saturday and then Monday of the following week for a 6-1-1 schedule, and in which the drug is administered Monday-Friday and then Monday-Tuesday of the following week for 5-2-2 schedule) per cycle. Treatment of the study drug, BLEX 404 Oral Liquid will begin at the same time receiving the first dose of azacitidine in this study.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.\n* Adequate baseline organ function defined by the criteria below: total bilirubin ≤ 1.5x the upper limit of normal (ULN) except for Gilbert's syndrome or indirect hyperbilirubinemia due to hemolysis; ALT ≤ 2.5x ULN; AST ≤ 2.5x ULN; creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2.\n* Women must be either of non-child bearing potential, or women with child-bearing potential and men with reproductive potential and a female partner of childbearing potential must either have had a prior vasectomy or agree to use effective contraception from time of Screening Visit until the Follow-Up Visit.\n\nExclusion Criteria:\n\n* Historical allergic events caused by mushroom.\n* Previous treatment with hypomethylating agent or known immediate or delayed hypersensitivity reaction to drugs chemically related to azacitidine that contraindicates the subjects' participation.\n* Patients with active infections or require treatments with immunosuppressive drugs at screening visit. However, patients require ongoing treatments with corticosteroids may be recruited.\n* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of BLEX 404 Oral Liquid.\n* Any serious and\u002For unstable pre-existing medical condition (including any advanced malignancy other than the disease under study), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures.\n* Any clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying hematologic disorder.\n* Active and uncontrolled infections of the following: hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus (HIV) infection. However, HBV and HCV carriers with viral load test of \"not detected\" or \"negative\" results may be recruited in this study.\n* Lactating female and women with a positive serum or urine pregnancy test at screening assessments.\n* (For Part II Interventional Study subjects only) No indication, in the opinion of the treating physician, for antibiotic prophylaxis within 2 weeks prior to study treatment.","20 Years",{"count":50,"type":21},52,[25],"This is a clinical trial to determine the safety, recommended dose level (RDL), and infection control of BLEX 404 Oral Liquid in combination with azacitidine in patients with International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2) or high-risk myelodysplastic syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML).",[54],"Myelodysplastic Syndrome (MDS)","2026-04-08",{"date":57,"type":33},"2026-04-13",{"date":59,"type":21},"2027-01-01",{"date":61,"type":21},"2028-12-31",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":70,"minAge":48,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100270623","phase-1-phase-iii-evaluate-the-safety-and-efficacy-of-blex-404-with-docetaxel-in-patients-with-advancedmetastatic-triple-negative-breast-cancer-100270623","NCT02802423","Phase I\u002FII, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced\u002FMetastatic Triple Negative Breast Cancer.","A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase IIA Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid With Adjuvant Chemotherapy in Patients With Triple Negative Breast Cancer (TNBC) After Surgery","Inclusion Criteria:\n\n1. Females aged 20 - 70 years old at the time of signing the ICF.\n2. Patients with histologically or pathologically diagnosed with advanced\u002Fmetastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.\n\n   1. ER =\\\u003C 10% by immunohistochemistry (IHC) tumor staining;\n   2. PR =\\\u003C 10% by IHC tumor staining;\n   3. HER2-negative defined as one of the following: 0 or 1+ by IHC, or 2+ by IHC and fluorescence in situ hybridization (FISH)-negative (ratio \\\u003C 2.0).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000\u002FμL; platelets count greater than or equal to 100,000\u002FμL; hemoglobin must be greater than or equal to 10 g\u002FdL (can be corrected by growth factor or transfusion).\n5. Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.\n6. Adequate renal function with: serum creatinine less than or equal to 1.3 mg\u002FdL or calculated creatinine clearance greater than or equal to 60 mL\u002Fminute according to the Cockcroft and Gault formula.\n7. Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen\u002Fprogesterone), from time of Screening Visit until 30 days after study drug discontinuation.\n8. Planning to receive Docetaxel monotherapy.\n9. Willing and able to comply with all aspects of the treatment protocol.\n10. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Patient with brain metastasis.\n2. Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.\n3. Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.\n4. Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.\n5. Known history of human immunodeficiency virus (HIV) infection.\n6. Existing anticancer treatment-related toxicities of Grades greater than or equal to 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).\n7. Patients with Grade \\> 2 neuropathy.\n8. Patient has an active infection requiring systemic therapy.\n9. History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study.\n10. Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT\u002FQTc (\\[QT interval\u002Fcorrected QT interval\\].\n11. Ascertained hypersensitivity to any component of investigational product used in the study.\n12. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.\n13. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases\u002Fmedical history.","FEMALE","70 Years",{"count":73,"type":21},44,[24,25],"The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.",[77],"Triple Negative Breast Cancer",[79,80,81],"TNBC","Breast cancer","Triple negative",{"date":57,"type":33},{"date":59,"type":21},{"date":85,"type":21},"2028-08-28",{"name":39,"class":40},""]